IMPORTANT SAFETY INFORMATION

CARDIOVASCULAR

Amplatzer Piccolo™ Occluder

IMPORTANT SAFETY INFORMATION

Rx Only

Indications and Usage

The AMPLATZER Piccolo™ Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

Contraindications

  • Weight < 700 grams at time of the procedure 
  • Age < 3 days at time of procedure
  • Coarctation of the aorta 
  • Left pulmonary artery stenosis 
  • Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension 
  • Intracardiac thrombus that may interfere with the implant procedure 
  • Active infection requiring treatment at the time of implant 
  • Patients with a PDA length smaller than 3 mm 
  • Patients with a PDA diameter that is greater than 4 mm at the narrowest portion

Warnings

  • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.  
  • Do not use the device if the sterile package is open or damaged. 
  • Use on or before the last day of the expiration month that is printed on the product packaging label.  
  • Patients who are allergic to nickel can have an allergic reaction to this device. 
  • Prepare for situations that require the removal of this device. Preparation includes access to a transcatheter snare kit and an on-site surgeon.  
  • Accurate measurements of the ductus are crucial for correct occluder size selection.  
  • Do not release the occluder from the delivery wire if either a retention disc protrudes into the pulmonary artery or aorta; or if the position of the occluder is not stable.  
  • Remove embolized devices. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter.

Precautions

  • This device should be used only by physicians who are trained in standard transcatheter techniques. Determine which patients are candidates for procedures that use this device. 
  • The physician should exercise clinical judgment in situations that involve the use of anticoagulants and antiplatelet drugs before, during, and/or after the use of this device. 
  • Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device placement, unless the patient has a significant risk for bleeding and is unable to be anti-coagulated. 
  • The device may be delivered via an anterograde (venous) or a retrograde (arterial) approach. However, in small infants (≤2 kg), the device should be delivered using the anterograde (venous) approach since small infants are at an increased risk for arterial injury. 
  • The AMPLATZER Piccolo™ Occluder contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days following implant. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should seek immediate medical attention if there is suspicion of an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted. 
  • Use in specific populations
    • Pregnancy — Minimize radiation exposure to the fetus and the mother.
    • Nursing mothers — There has been no quantitative assessment for the presence of leachables in breast milk.
  • Store in a dry place. 
  • Do not use contrast power injection with delivery catheter. 

Potential Adverse Events

Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:

  • Air embolus 
  • Allergic dye reaction 
  • Allergic drug reaction 
  • Anesthesia reactions 
  • Apnea 
  • Arrhythmia 
  • Bacterial endocarditis 
  • Bleeding 
  • Cardiac perforation 
  • Cardiac tamponade 
  • Chest pain 
  • Device embolization 
  • Device erosion 
  • Death 
  • Fever 
  • Headache/migraine 
  • Hemolysis 
  • Hematoma 
  • Hypertension 
  • Hypotension 
  • Infection 
  • Myocardial infarction 
  • Palpitations 
  • Partial obstruction of aorta 
  • Partial obstruction of pulmonary artery
  • Pericardial effusion 
  • Pericarditis 
  • Peripheral embolism 
  • Pleural effusion 
  • Pulmonary embolism  
  • Re-intervention for device removal
  • Respiratory distress 
  • Stroke 
  • Thrombus 
  • Transient ischemic attack 
  • Valvular regurgitation 
  • Vascular access site injury 
  • Vascular occlusion 
  • Vessel perforation

Amplatzer™ PFO Occluder

INDICATIONS, SAFETY & WARNINGS

Rx Only

Indications and Usage

The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

Contraindications

  • Patients with intra-cardiac mass, vegetation, tumor or thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
  • Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size.
    Patients with anatomy in which the AMPLATZER™ PFO device size required would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.
  • Patients with other source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.
  • Patients with active endocarditis or other untreated infections.

Warnings

  • Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO Closure following standard of care.
  • Do not use this device if the sterile package is open or damaged.
  • Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon.
  • Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.
  • Patients who are allergic to nickel can have an allergic reaction to this device.
  • This device should be used only by physicians who are trained in standard transcatheter techniques.
  • Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.
  • Do not release the device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). If the device interferes with an adjacent cardiac structure, recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment.
  • Ensure there is sufficient distance from the PFO to the aortic root or SVC (typically defined as 9 mm or greater as measured by echo). See Figure 6. and Figure 7.

Precautions

  • The safety and effectiveness of the AMPLATZER™ PFO Occluder has not been established in patients (with):Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited to patients 18 to 60 years old
    • A hypercoagulable state including those with a positive test for a anticardiolipin antibody (IgG or IgM), Lupus anticoagulant, beta-2 glycoprotein-1 antibodies, or persistently elevated fasting plasma homocysteine despite medical therapy
    • Unable to take antiplatelet therapy
    • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥50% luminal stenosis
    • Acute or recent (within 6 months) myocardial infarction or unstable angina
    • Left ventricular aneurysm or akinesis
    • Mitral valve stenosis or severe mitral regurgitation irrespective of etiology
    • Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation
    • Mitral or aortic valve vegetation or prosthesis
    • Aortic arch plaques protruding greater than 4 mm into the aortic lumen
    • Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%
    • Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
    • Uncontrolled hypertension or uncontrolled diabetes mellitus
    • Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event
    • Arterial dissection as cause of stroke
    • Index stroke of poor outcome (modified Rankin score greater than 3)
    • Pregnancy at the time of implant
    • Multi-organ failure
  • Use on or before the last day of the expiration month that is printed on the product packaging label.
  • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to re-sterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • The AMPLATZER™ PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
  • Store in a dry place.
  • Pregnancy – Minimize radiation exposure to the fetus and the mother.
  • Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.

Adverse Events

Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus Allergic drug reaction; Allergic dye reaction; Allergic metal reaction: Nitinol (nickel, titanium), platinum/iridium, stainless steel (chromium, iron, manganese, molybdenum, nickel); Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding ; Brachial plexus injury; Cardiac perforation; Cardiac tamponade; Cardiac thrombus; Chest pain; Device embolization; Device erosion; Deep vein thrombosis; Death; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hypertension/hypotension; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Palpitations; Pericardial effusion; Pericardial tamponade; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for residual shunt/device removal; Sepsis; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; Vessel perforation

CardioMEMS™ HF System

IMPORTANT SAFETY INFORMATION

Rx Only

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications and Usage: The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

Contraindications: The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to the following: Infection, Arrhythmias, Bleeding, Hematoma, Thrombus, Myocardial infarction, Transient ischemic attack, Stroke, Death, and Device embolization.

Refer to the User's Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Confirm Rx Insertable Cardiac Monitor

INDICATIONS, SAFETY & WARNINGS

Confirm Rx Insertable Cardiac Monitor

Rx Only

Indications: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx™ ICM has not been specifically tested for pediatric use.

Contraindications: There are no known contraindications for the insertion of the Confirm Rx™ ICM. However, the patient's particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User's Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Additional information: Clinicians must log onto Merlin.net™ Patient Care Network to view transmissions from patients’ Confirm Rx™ ICM. On Merlin.net™ PCN they can configure transmission schedules and enable or disable features on a patient's myMerlin™ for Confirm Rx™ ICM mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.

Limitations: Patients may use their own Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx™ ICM using the myMerlin™ for Confirm Rx™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ for Confirm Rx™ mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was not sent successfully. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing.

An Abbott mobile transmitter is available for patients without their own compatible mobile device.

 

HeartMate 3™ Left Ventricular Assist Device

IMPORTANT SAFETY INFORMATION

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The HeartMate​ 3TM​ Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.

Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or device thrombosis.

Masters 15mm pediatric heart valve

INDICATIONS FOR USE

The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning mitral or aortic heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic heart valve. The sizer model 905-15 is indicated to confirm size selection of the 15AHPJ-505 and 15MHPJ-505 valves.

CONTRAINDICATIONS

The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy. The sizer model 905-15 is contraindicated for use with any devices other than the 15 AHPJ-505 and 15MHPJ-505 valves. Any sizer sterilization method other than steam is contraindicated.

WARNINGS

Valve

  • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Use only St. Jude Medical™ mechanical heart valve sizers.
  • Do not use if:
    • The valve has been dropped, damaged, or mishandled in anyway.
    • The expiration date has elapsed.
    • The tamper-evident container seal or inner/ outer tray seals are damaged, broken, or missing.
  • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
  • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM™ Masters Series Mechanical Heart Valve sizes, use the smaller prosthetic valve size.
  • The outer tray is not sterile, and should not be placed in the sterile field.
  • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
  • Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude Medical™ leaflet tester to gently test valve leaflet mobility.
  • Place sutures in the outer half of the valve sewing cuff.
  • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
  • Use only SJM™ Valve Holder/Rotators to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/rotator is intended for single use only and should be discarded after surgery.
  • The two retention sutures on the valve holder/ rotator must be cut and removed before the valve can be rotated.
  • Do not pass catheters or other instruments through St. Jude Medical™ mechanical heart valves. This could result in scratched or damaged valve components, leaflet fracture, or dislodgment.
  • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.

PRECAUTIONS

Valve

  • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
  • Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the valve.
  • Before placing sutures in the valve sewing cuff, verify that the valve is mounted correctly on the valve holder/rotator.
  • To avoid structural damage, the valve must be rotated in the fully open position.
  • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve.
  • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
  • Implantation of a prosthetic valve too large for the annulus may result in increased risk of damage to the conductive system, obstruction of the left ventricular outflow tract, impairment of valve mobility, damage to the left circumflex artery, and damage to surrounding tissues or cardiac structures including obstruction and/or distortion of adjacent cardiac structures.
  • NOTE: PROSPECTIVE DATA TO SUPPORT SAFETY AND EFFECTIVENESS OF THE 15-mm HP VALVE IMPLANTED IN THE AORTIC POSITION ARE NOT CURRENTLY AVAILABLE.

Sizer

  • Instruments must be cleaned and sterilized prior to use.
  • Do not use cracked, deformed, discolored/rusted, or damaged instruments.
  • Improper cleaning may result in an immunological or toxic reaction.
  • Instrument sterilization temperature must not exceed 280°F (138°C).
  • Do not bend flexible instrument handles beyond a 90° angle.
  • Instruments must be sterilized in a tray or container that is permeable to steam.
  • Do not expose instruments to cleaning or rinse agents that are not compatible with polysulfone or polyphenylsulfone.

POTENTIAL ADVERSE EVENTS

Complications associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, heart block requiring pacemaker implant, prosthetic failure, adjacent cardiac structure interference, heart failure, stroke, myocardial infarction, or death. Any of these complications may require reoperation or explantation of the device.

MitraClip

Risks, Warnings, and Precautions

What Are the Possible Risks 1 Year After the Procedure?

The most common serious risks observed within 1 year of the MitraClip procedure in patients enrolled in the PR DMR Cohort include:

  • Death from any cause occurred in 30 out of 127 patients (23.6%)
  • Stroke occurred in 3 out of 127 patients (2.4%). Stroke is a condition where lack of blood flow to the brain causes rapid loss of brain function
  • Ventilation longer than 48 hours occurred in 6 out of 127 patients (4.7%). This means that the use of a ventilator was required more than two days to help a patient breathe
  • Major vascular complications occurred in 9 out of 127 patients (7.1%). Examples include a hematoma (large blood clot under the skin) or damage to the artery and surrounding veins where the catheter was inserted that requires surgical repair
  • Bleeding events occurred in 25 out of 127 patients (19.7%). This refers to a loss of blood related to the procedure that required blood transfusion of 2 or more unit
  • Kidney failure occurred in 5 out of 127 patients (3.9%)
  • Gastrointestinal complications occurred in 3 out of 127 patients (2.4%)
  • Septicemia occurred in 6 out of 127 patients (4.7%). Septicemia is a serious infection of the blood often caused by bacteria

Warnings

  • MitraClip therapy should only be used in patients with significant, symptomatic, degenerative mitral regurgitation who are too sick for mitral valve surgery.
  • MitraClip therapy is intended to reduce mitral regurgitation. If mitral regurgitation is not reduced enough, you may not get the full treatment benefits of reduced hospitalizations and improvement in heart failure symptoms and quality of life expected from MitraClip therapy.

Precautions

  • MitraClip therapy should only be used in patients considered to be too sick for surgery. This is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, based on the presence of one or more surgical risk factors.
  • The major clinical benefits of MitraClip therapy are reduction of mitral regurgitation, resulting in reduced hospitalizations and improvement in heart failure symptoms and quality of life. No benefit on how long a patient survives following MitraClip therapy has been demonstrated. How long the MitraClip device will last is unknown at this time.
  • The first MitraClip device was implanted in 2003 and laboratory testing supports durability of the device over a period of 15 years. Regular medical follow-up is essential to evaluate how the MitraClip device is performing. Notify your doctor immediately if you experience the return of any symptoms related to mitral regurgitation.
  • Patients who have undergone MitraClip therapy should receive prophylactic antibiotic therapy before any medical or dental procedure to minimize the possibility of infection.
  • The safety and effectiveness of MitraClip therapy have not been established in patients who have functional (also called secondary) mitral regurgitation.
  • The safety and effectiveness of MitraClip therapy have not been established in patients who have specific mitral valve anatomy that may interfere with proper placement and positioning of the MitraClip device:
    • A mitral valve opening that is too small
    • Calcified mitral valve leaflets
    • A cleft of the mitral valve leaflet
    • A leaflet flail width or leaflet flail gap that is too large
  • MitraClip therapy has not been tested in pregnant women or children or infants, and the device may not work for these patients.

Supera Peripheral Stent System

INDICATIONS

The Supera Peripheral Stent System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm.

CONTRAINDICATIONS

The Supera Peripheral Stent System is contraindicated in:

  • patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
  • patients who cannot receive antiplatelet or anticoagulation therapy. Based on in vivo thrombogenicity testing, the device should not be used in patients who cannot be anticoagulated as there may be some thrombus formation in the absence of anticoagulation.

WARNINGS

  • This device is intended for single-use only. Do not reuse. Do not resterilize. Do not use if the package is opened or damaged.
  • Use this device prior to the “Use By” date as specified on the device package label. Store in a dry, dark, cool place.
  • DO NOT use if it is suspected that the sterility of the device has been compromised.
  • Persons with known hypersensitivities to Nitinol and / or its components (e.g. nickel titanium) may suffer an allergic reaction to this implant.
  • Administer appropriate antiplatelet therapy pre- and post-procedure.
  • Careful attention should be paid when sizing and deploying the stent to prevent stent elongation. In the SUPERB clinical study, stent elongation was associated with a decrease in patency at 12 months.

PRECAUTIONS

The Supera Peripheral Stent System should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device.

  • The long-term safety and effectiveness of the Supera Peripheral Stent System has not been established beyond three years.
  • The safety and effectiveness of the Supera Peripheral Stent System has not been established in patients who:
    • are less than 18 years old
    • are pregnant or lactating
    • have in-stent restenosis of the target lesion
    • have known hypersensitivity to any component of the stent system (e.g., nickel)
    • cannot tolerate contrast media and cannot be pre-treated
    • have uncontrolled hypercoaguability and / or other coagulopathy
  • This device is not designed for use with contrast media injection systems or power injection systems.
  • The flexible design of the Supera stent may result in variation in the deployed stent length.

Magnetic Resonance Imaging (MRI)

A patient with this device can be scanned safely only under specific conditions. Failure to follow the conditions may result in severe injury.

Non-clinical testing has demonstrated the Supera Stents are MR Conditional for lengths up to 250 mm. A patient with this stent can be scanned safely, immediately after placement, under the following conditions:

  • Static magnetic field of 1.5 or 3.0 Tesla
  • Highest spatial gradient magnetic field of 2,500 Gauss/cm or less
  • Maximum MR whole-body-averaged specific absorption rate (SAR) of
    • 2 W/kg for landmarks (i.e. center of RF coil) above the umbilicus
    • 1 W/kg for landmarks below the umbilicus and above the mid-thigh
    • 0.5 W/kg for landmarks below the mid-thigh

for 15 minutes of scanning (per pulse sequence), operating in the Normal Operating Mode (i.e., MR system mode of operation where there is no physiological stress to the patient). The legs of the patient should not be touching during the procedure.

POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to:

  • Abrupt closure
  • Allergic reaction (contrast medium; drug; stent material)
  • Amputation or limb loss
  • Aneurysm or pseudoaneurysm in vessel or at vascular access site
  • Angina or coronary ischemia
  • Arrhythmia (including premature beats, bradycardia, atrial or ventricular tachycardia, atrial or ventricular fibrillation)
  • Arteriovenous fistula
  • Bleeding complications requiring transfusion or surgical intervention
  • Death
  • Detachment of a system component or implantation in an unintended site
  • Embolization, arterial or other (e.g. air, tissue, plaque, thrombotic material, or stent)
  • Emergent surgery
  • Fever
  • Abrupt closure
  • Allergic reaction (contrast medium; drug; stent material)
  • Amputation or limb loss
  • Aneurysm or pseudoaneurysm in vessel or at vascular access site
  • Angina or coronary ischemia
  • Arrhythmia (including premature beats, bradycardia, atrial or ventricular tachycardia, atrial or ventricular fibrillation)
  • Arteriovenous fistula
  • Bleeding complications requiring transfusion or surgical intervention
  • Death
  • Detachment of a system component or implantation in an unintended site
  • Embolization, arterial or other (e.g. air, tissue, plaque, thrombotic material, or stent)
  • Emergent surgery
  • Fever
  • Hematoma or hemorrhagic event, with or without surgical repair
  • Hyperperfusion syndrome
  • Hypertension / Hypotension
  • Infection
  • Myocardial infarction
  • Pain (leg, foot, and/or insertion site)
  • Partial stent deployment
  • Peripheral nerve injury
  • Pulmonary embolism
  • Renal failure or insufficiency
  • Restenosis of vessel in stented segment
  • Shock
  • Stent malapposition or migration, which may require emergency surgery to remove stent
  • Stent strut fracture
  • Thrombosis or occlusion
  • Stroke
  • Transient ischemic attack
  • Venous thromboembolism
  • Vessel dissection, perforation or rupture
  • Vessel spasm or recoil
  • Worsening claudication or rest pain

Prior to use, please reference the Instructions for Use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions, and adverse events.

DIABETES CARE

FreeStyle Libre 14 day

Full INDICATIONS AND IMPORTANT SAFETY INFORMATION

The FreeStyle Libre 14 day Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions. The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires a prescription.

CONTRAINDICATIONS: 

The FreeStyle Libre 14 day Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS: 

  • Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
  • Check Sensor glucose readings by conducting a fingerstick test with a blood glucose meter under the following conditions, when Sensor glucose readings may not be accurate and should not be used to make a diabetes treatment decision:
    • If you suspect that your reading may be inaccurate for any reason
    • When you are experiencing symptoms that may be due to low or high blood glucose
    • When you are experiencing symptoms that do not match the Sensor glucose readings
    • During the first 12 hours of wearing a FreeStyle Libre 14 day Sensor
    • During times of rapidly changing glucose (more than 2 mg/dL per minute)
    • When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow
    • In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
  • When you see the Check Blood Glucose symbol, you must check your blood glucose with a blood glucose meter before making any treatment decisions. Sensor readings may not accurately reflect blood glucose levels.
  • Hypoglycemic unawareness: The System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you of a hypoglycemic event without you scanning your Sensor.
  • No alarms without a Sensor scan: The System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose event unless you scan your Sensor. For example, the System does not have an alarm that can alert or wake you when you are sleeping in the case of low or high glucose.
  • Choking hazard: The FreeStyle Libre 14 day system contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS

Below are important cautions and limitations to keep in mind so you can use the System safely. They are grouped into categories for easy reference.

What to know about Alarms/Alerts:

  • There are NO alarms or alerts unless you scan the Sensor.

What to know before using the System:

  • Review all product information before use.
  • Take standard precautions for transmission of blood borne pathogens to avoid contamination.

Who should not use the System:

  • Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate. In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults.
  • Do not use the System in critically ill patients. The System is not approved for use in these patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the System. Sensor glucose readings may be inaccurate in critically ill patients.
  • Do not use the System in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations.
  • Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

  • The Sensor can be worn for up to 14 days.
  • Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System. Contact your health care professional before continuing to use the System.
  • Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site.
  • The System uses all available glucose data to give you readings so you should scan your Sensor at least once every 8 hours for the most accurate performance. Scanning less frequently may result in decreased performance.
  • Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results.
  • If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

  • Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause inaccurate Sensor glucose readings. While you don’t need to keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F and 77°F. Do not freeze.
  • Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

  • Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
  • Do NOT use if Sensor Kit contents are past expiration date.
  • Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know before you Apply the Sensor:

  • The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
  • Clean the application site and ensure that it is dry prior to Sensor insertion. This helps the Sensor stay attached to your body.
  • Clean hands prior to Sensor handling/insertion to help prevent infection.
  • Change the application site for the next Sensor application to prevent discomfort or skin irritation.
  • Sensor placement is not approved for sites other than the back of the arm. If placed in other areas, the Sensor may not function properly.
  • Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

  • Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about interfering substances such as Vitamin C and Aspirin:

  • Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body.
  • Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels. However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood.

What to know about X-Rays:

  • The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

  • If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it and apply a new one.
  • If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor and apply a new one.

What to do if you are dehydrated:

  • Severe dehydration and excessive water loss may cause inaccurate Sensor glucose readings. If you believe you are suffering from dehydration, consult your health care professional immediately.

What to know about the Reader’s Built-in Meter:

  • The FreeStyle Libre 14 day Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error or cause the Reader’s built-in meter to not turn on or start a test. The Reader's built-in meter does not have ketone testing functionality.
  • The Reader’s built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
  • The Reader’s built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
  • See Using the Reader’s Built-in meter section for additional important information on the use of the Reader’s built-in meter.

Where to charge your Reader:

  • Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.

FreeStyle Libre 2

IMPORTANT USE INFORMATION INDICATIONS FOR USE:

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

COMPATIBLE DEVICES, APPS, AND SOFTWARE:

For a list of compatible devices, apps, and software that can be used with the FreeStyle Libre 2 Sensor, please go to:

www.FreeStyleLibre.us/support/overview.html

Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings.

FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check www.FreeStyleLibre.com for more information about device compatibility before upgrading your phone or its operating system.

CONTRAINDICATIONS:

Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS:

  CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Before you use the FreeStyle Libre 2 System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial give you quick access to important aspects and limitations of the System. The User’s Manual includes all safety information and instructions for use. Talk to your health care professional about how you should use your Sensor glucose information to help manage your diabetes.

Failure to use the System according to the instructions for use may result in you missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If your glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.

  • Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
  • Use your blood glucose meter to make diabetes treatment decisions when you see the symbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number.
  • If you are using FreeStyle Libre 2 app, you must have access to a blood glucose monitoring system as the App does not provide one.
  • Choking hazard: The System contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS:

Below are important cautions and limitations to keep in mind so you can use the System safely. They are grouped into categories for easy reference.

What to know about Reader Alarms:

  • For you to receive alarms, they must be on and your Reader should be within 20 feet of you at all times. The transmission range is 20 feet unobstructed. If you are out of range, you may not receive glucose alarms.
  • To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on.
  • Alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose.

What to know about App Alarms:

  • For you to receive alarms, your phone should be within 20 feet of you at all times. The transmission range is 20 feet unobstructed. If you are out of range, you may not receive alarms. If you want to receive the App's optional alarms, make sure these are turned on.
  • Do not force close the App. The App must be running in the background to receive alarms. If you force close the App you will not receive alarms.
    Re-open the App to ensure you will receive alarms.
  • If you restart your phone, open your App to make sure it’s working properly.
  • Glucose alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose.
  • The App will ask for phone permissions which are needed to receive alarms. Allow these permissions when requested.
  • Check to make sure that you have the correct phone settings and permissions enabled. If your phone is not configured properly, you will not be able to use the App, so you will not receive alarms or be able to check your glucose.
    • iPhones are to be configured as follows:
      • In the phone settings, keep Bluetooth ON
      • In the phone settings for the App, allow the App to access Bluetooth
      • In the phone settings for the App under Notifications, keep Allow Critical Alerts ON
    • Android Phones are to be configured as follows:
      • In the phone settings, keep Bluetooth ON
      • In the phone settings for the App, keep Do Not Disturb Access permission ON
  • If your phone is not configured correctly, the App will be in "Alarms Unavailable" state and you will not be able to check your glucose or receive any alarms, including the Urgent Low Glucose Alarm.
  • To turn on Critical Alerts, Do Not Disturb Permission, and Bluetooth, follow the instructions in the App.
  • For Android, you may need to add the FreeStyle Libre 2 app to the list of the apps that will not be restricted or put to sleep.
  • If you adjust the phone ringer volume (iPhone) or Media volume (Android) to silent or use the phone do not disturb setting, keep ‘Override Do Not Disturb’ setting in the App ON for Low Glucose, High Glucose, and Signal Loss Alarms to ensure you receive audible alarms.
  • You should disconnect headphones or speakers from your phone when you are not using them as you may not hear audio for alarms. If using headphones, keep them in your ears.
  • If you are using peripheral devices connected to your phone, such as wireless headphones or a smartwatch, you may receive alarms on only one device or peripheral, not all.
  • Keep your phone well charged and turned on.
  • Disable your phone’s automatic operating system updates. After an operating system update, open your App and check your device settings to make sure it’s working properly.
  • Some operating system features may impact your ability to receive alarms. For example, if you use an iPhone and the iOS Screen Time feature, add FreeStyle Libre 2 to the list of always allowed apps to ensure that you receive alarms or if you use an Android Phone do not use the Android Digital Wellbeing app.

What to know before using the System:

  • Review all product information before use.
  • Take standard precautions for transmission of blood borne pathogens to avoid contamination.
  • Make sure that your devices and Sensor kits are kept in a safe place, and maintain your devices under your control during use. This is important to help prevent anyone from accessing or tampering with the System.

Who should not use the System:

  • Do not use the System in people less than 4 years of age. The System is not cleared for use in people under 4 years of age.
  • Do not use the System if you are pregnant, on dialysis, or critically ill. The System is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may affect performance of the System.
  • Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

  • Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full wear duration specified by your Sensor insert and help prevent it from falling off early.
  • The Sensor can be worn for up to the wear duration specified by your Sensor insert. Remember to always have your next Sensor available before your current one ends so you can keep getting your glucose readings.
  • You must scan the Sensor to get your real-time current glucose level as both the Reader and App will not provide this information without a scan.
  • In the event that your Sensor stops working and you do not have another Sensor readily available, you must use an alternate method to measure your glucose levels and inform your treatment decisions.
  • The System is designed to detect certain conditions which may occur where the Sensor is not working as intended and shut it off, telling you to replace your Sensor. This may occur if the Sensor gets knocked off from the skin or if the System detects that the Sensor may not be performing as intended. Contact Customer Service if you receive a Replace Sensor message before the end of the wear duration specified by your Sensor insert. Customer Service is available at 1-855-632-8658 ​7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
  • Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System. Contact your health care professional before continuing to use the System.
  • Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable low readings. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the Sensor. Contact Customer Service if your Sensor becomes loose or falls off before the end of the wear period. Customer Service is available at 1-855-632-8658 ​7 Days a Week from 8AM to 8PM Eastern Standard Time.
  • Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause unreliable low results.
  • If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

  • Store the Sensor Kit between 36°F and 82°F. Storage outside of this range may cause inaccurate Sensor glucose readings.
  • If you suspect that the temperature may exceed 82°F (for example, in an unairconditioned home in summer), you should refrigerate your Sensor Kit. Do not freeze your Sensor Kit.
  • Store your Sensor Kit in a cool, dry place. Do not store your Sensor Kit in a parked car on a hot day.
  • Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

  • Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
  • Do NOT use if Sensor Kit contents are past expiration date.
  • Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know about the System:

  • The FreeStyle Libre 2 System is intended for use by a single person. It must not be used by more than one person due to the risk of misinterpreting glucose information.
  • FreeStyle Libre 2 app and FreeStyle Libre 2 Readers do not share data.

What to know before you Apply the Sensor:

  • The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.

safety-information-code

  • Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full wear duration specified by your Sensor insert and help prevent it from falling off early.
  • Clean hands prior to Sensor handling/insertion to help prevent infection.
  • Change the application site for the next Sensor application to prevent discomfort or skin irritation.
  • Only apply the Sensor to the back of the upper arm. If placed in other areas, the Sensor may not function properly.
  • Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

  • Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about X-Rays:

  • The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

  • If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it, apply a new one, and contact Customer Service.
  • If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor, apply a new one, and contact Customer Service. Customer Service is available at 1-855-632- 8658 ​7 Days a Week from 8AM to 8PM Eastern Standard Time.

What to know about the Reader’s Built-in Meter:

  • The FreeStyle Libre 2 Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error or cause the Reader’s built-in meter to not turn on or start a test. The Reader’s built-in meter does not have ketone testing functionality.
  • The Reader’s built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
  • The Reader’s built-in meter is not for use on neonates, in critically ill patients, or for diagnosis or screening of diabetes.
  • See Using the Reader’s Built-in Meter for additional important information on the use of the Reader’s built-in meter.

What to know about charging your Reader:

  • Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.
  • The maximum surface temperature of the Reader and/or the power adapter could go as warm as 120 °F when it's charging or 117 °F during normal use. Under these conditions, do not hold the Reader or the power adapter for five minutes or more. People with disorders of peripheral circulation or sensation should use caution at this temperature.

INTERFERING SUBSTANCES:

Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins. Some supplements, including cold remedies such as Airborne® and Emergen-C®, may contain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor. See your healthcare professional to understand how long ascorbic acid is active in your body.

FreeStyle Libre 3

IMPORTANT SAFETY INFORMATION INDICATIONS FOR USE:

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

COMPATIBLE DEVICES, APPS, AND SOFTWARE:

For a list of compatible devices, apps, and software that can be used with the FreeStyle Libre 3 Sensor, please go to:

www.FreeStyleLibre.us/support/overview.html

Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings.

The FreeStyle Libre 3 app runs on Apple iOS and Android smart devices. Please check  www.FreeStyleLibre.com for more information about device compatibility before upgrading your phone or its operating system.

CONTRAINDICATIONS:

Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS:

  • Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
  • Use your blood glucose meter to make diabetes treatment decisions when you see the symbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number.
  • You must have access to a blood glucose monitoring system as the App does not provide one.
  • Choking hazard: The System contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS:

Below are important cautions and limitations to keep in mind so you can use the System safely. They are grouped into categories for easy reference.

What to know about App Alarms:

  • For you to receive alarms, your phone should be within 33 feet of you at all times. The transmission range is 33 feet unobstructed. If you are out of range, you may not receive alarms. If you want to receive the App's optional alarms, make sure these are turned on.
  • For iPhone, do not force close the App. The App must be running in the background to receive alarms. If you force close the App you will not receive alarms. Re-open the App to ensure you will receive alarms.
  • If you restart your phone, open your App to make sure it’s working properly.
  • The App will ask for phone permissions which are needed to receive alarms. Allow these permissions when requested.
  • Your phone must have a Bluetooth connection with your Sensor to receive glucose readings and glucose alarms. In the phone settings, keep Bluetooth ON. For iPhones, in the phone settings for the App, allow the App to access Bluetooth.
  • Check to make sure that you have the correct phone settings and permissions enabled. If your phone is not configured properly, you will not be able to use the App, so you will not receive alarms or be able to check your glucose.
    • iPhones: In the phone settings for the App under Notifications, keep Allow Critical Alerts ON
    • Android Phones: In the phone settings for the App, keep Do Not Disturb Access permission ON
  • If your phone is not configured correctly, the App will be in "Alarms Unavailable" state and you will not be able to check your glucose or receive any alarms, including the Urgent Low Glucose Alarm.
  • To turn on Critical Alerts (iPhone) / Do Not Disturb Permission (Android Phone), follow the instructions in the App.
  • For Android Phones, you may need to add the FreeStyle Libre 3 app to the list of apps that will not be restricted or put to sleep.
  • If you adjust the phone ringer volume (iPhone) or Media volume (Android Phone) to silent or use the phone Do Not Disturb setting, keep ‘Override Do Not Disturb’ setting in the App ON for Low Glucose, High Glucose, and Signal Loss Alarms to ensure you receive audible alarms.
  • You should disconnect headphones or speakers from your phone when you are not using them as you may not hear audio for alarms. If using headphones, keep them in your ears.
  • If you are using peripheral devices connected to your phone, such as wireless headphones or a smartwatch, you may receive alarms on only one device or peripheral, not all.
  • Keep your phone well charged and turned on.
  • Disable your phone’s automatic operating system updates. After an operating system update, open your App and check your device settings to make sure it’s working properly.
  • Some operating system features may impact your ability to receive alarms. For example, if you use an iPhone and the iOS Screen Time feature, add the FreeStyle Libre 3 app to the list of Always Allowed apps to ensure that you receive alarms or if you use an Android Phone do not use the Android Digital Wellbeing app.

What to know before using the System:

  • Review all product information before use.
  • Take standard precautions for transmission of blood borne pathogens to avoid contamination.
  • Make sure that your devices and Sensor kits are kept in a safe place, and maintain your devices under your control during use. This is important to help prevent anyone from accessing or tampering with the System.

Who should not use the System:

  • Do not use the System in people less than 4 years of age. The System is not cleared for use in people under 4 years of age.
  • Do not use the System if you are pregnant, on dialysis, or critically ill. The System is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may affect performance of the System.
  • Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

  • Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off early.
  • The Sensor can be worn for up to 14 days. Remember to always have your next Sensor available before your current one ends so you can keep getting your glucose readings.
  • In the event that your Sensor stops working and you do not have another Sensor readily available, you must use an alternate method to measure your glucose levels and inform your treatment decisions.
  • The System is designed to detect certain conditions which may occur where the Sensor is not working as intended and shut it off, telling you to replace your Sensor. This may occur if the Sensor gets knocked off from the skin or if the System detects that the Sensor may not be performing as intended. Contact Customer Service if you receive a Replace Sensor message before the end of the 14 day wear period. Customer Service is available at 1-855-632-8658 ​7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
  • Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System. Contact your health care professional before continuing to use the System.
  • Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable low readings. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the Sensor. Contact Customer Service if your Sensor becomes loose or falls off before the end of the wear period. Customer Service is available at 1-855-632-8658 ​7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.
  • Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for resterilization. Further exposure to irradiation may cause unreliable low results.
  • If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

  • Store the Sensor Kit between 36°F and 82°F. Storage outside of this range may cause inaccurate Sensor glucose readings.
  • If you suspect that the temperature may exceed 82°F (for example, in an unairconditioned home in summer), you should refrigerate your Sensor Kit. Do not freeze your Sensor Kit.
  • Store your Sensor Kit in a cool, dry place. Do not store your Sensor Kit in a parked car on a hot day.
  • Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

  • Do NOT use if the Sensor Kit package or Sensor Applicator appear to be damaged or if tamper label indicates Sensor Applicator has already been opened due to risk of no results and/or infection.
  • Do NOT use if Sensor Kit contents are past expiration date.

What to know about the System:

  • The FreeStyle Libre 3 System is intended for use by a single person. It must not be used by more than one person due to the risk of misinterpreting glucose information.

What to know before you Apply the Sensor:

  • Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off early.
  • Clean hands prior to Sensor handling/insertion to help prevent infection.
  • Change the application site for the next Sensor application to prevent discomfort or skin irritation.
  • Only apply the Sensor to the back of the upper arm. If placed in other areas, the Sensor may not function properly.
  • Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

  • Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about X-Rays:

  • The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

  • If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it, apply a new one, and contact Customer Service.
  • If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor, apply a new one, and contact Customer Service. Customer Service is available at 1-855-632-8658 ​7 Days a Week from 8AM to 8PM Eastern Time; excluding holidays.

INTERFERING SUBSTANCES:

Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins. Some supplements, including cold remedies such as Airborne® and Emergen-C®, may contain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor. See your health care professional to understand how long ascorbic acid is active in your body.

 

The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners.

No use of any Abbott trademark, trade name, or trade dress in this site may be made without prior written authorization of Abbott Laboratories, except to identify the product or services of the company.

This website and the information contained herein is intended for use by residents of the United States.

ADC-05596 v13.0 05/22

NEUROMODULATION

Spinal Column Stimulation (SCS) Systems

Intended Use

This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.

Indications For Use

Abbott Medical spinal cord stimulation (SCS) systems are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, nonsurgical back pain (without prior surgery and not a candidate for back surgery), and diabetic peripheral neuropathy of the lower extremities.

Contraindications

This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.

MRI Safety Information

Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. 

For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals). 

For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html

Warnings

The following warnings apply to this neurostimulation system.

Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients. 

Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. 

Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 

Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure. 

  • Use bipolar electrosurgery only.

  • Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.

  • Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.

  • Set the electrosurgery device to the lowest possible energy setting.

  • Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.

Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.

Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system.

Interference with other devices. Some of this system’s electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Avoid placing equipment components directly over other electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected.

Operation of machines, equipment, and vehicles. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. However, current data shows that most patients using BurstDR™ stimulation therapy do not experience paresthesia. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment.

Explosive and flammable gasses. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of these devices could cause them to ignite, causing severe burns, injury, or death.

Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to avoid damage. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing.

Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.

Use in patients with diabetes. Surgical complications and adverse effects may be more frequent and severe in patients with diabetes. The following additional considerations should be made for patients with diabetes:

  • A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) ≥8% (64 mmol/mol).
  • Monitor the patient’s blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes.
  • Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes.

Stimulation modes. The BurstDR™ stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population.

Device components. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient.

Device modification. Equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.

Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (that is, jailbroken).

Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.

IPG disposal. Return all explanted IPGs to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.

Product materials. Neurostimulation systems have materials that come in contact or may come in contact with tissue. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted.

Precautions

The following precautions apply to this neurostimulation system.

General Precautions
  • Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.

  • Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.

  • Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.

  • Implantation of two systems. If two systems are implanted, ensure that at least 20 cm (8 in.) separates the implanted IPGs to minimize unintended interaction with other system components.

  • Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.
  • Implant healing. While charging the generator, patients may perceive an increase in temperature at the generator site. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation.
  • High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations occur, the device should be turned off immediately.

  • Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
  • Consumer goods and electronic devices. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) away from the generator and avoid placing any smart device in a pocket near the generator. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support.
  • Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) six to eight weeks after implantation of a neurostimulation system. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation.
  • Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system.

  • Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient.

Sterilization and Storage
  • Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.

  • Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind.

Handling and Implementation
  • Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.
  • Recharge-by-date. A recharge‑by date is printed on the packaging. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation.
  • Handle the device with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.

  • Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

  • Package or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to Abbott Medical for evaluation.

  • Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation.

  • System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.

Hospitals and Medical Environments
  • High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.

  • Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.

  • External defibrillators. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.

  • Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Home and Occupational Environments
  • Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation.
    Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Patients should cautiously approach such devices and should request help to bypass them. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly.

  • Scuba diving or hyperbaric chambers. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician.

  • Wireless use restrictions. In some environments, the use of wireless functions (for example, Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: 

  • Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately

  • Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure

  • Stimulation in unwanted places (such as radicular stimulation of the chest wall) 

  • Lead migration, causing changes in stimulation or reduced pain relief 

  • Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space 

  • Cerebrospinal fluid (CSF) leakage 

  • Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant 

  • Persistent pain at the electrode or IPG site 

  • Seroma (mass or swelling) at the IPG site

  • Allergic or rejection response to implant materials 

  • Implant migration or skin erosion around the implant 

  • Battery failure

  • Changes in blood glucose levels in response to any adverse effect 

    NOTE: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate preoperative glycemic control. For adverse effects observed in the use of diabetic peripheral neuropathy, refer to the clinical summaries manual for SCS systems.

Safety And Effectiveness Studies

For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system.  

21 CR 801.109(b)  The label of the device, other than surgical instruments, bears:

(1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the word “physician,” “dentist,” “veterinarian,” or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and 

(2) The method of its application or use.

 

23-78280 MAT-2215216 v4.0 | Item approved for U.S. use only.

Dorsal Root Ganglion Therapy (DRG) Therapy

Prescription And Safety Information

Read this section to gather important prescription and safety information. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. 

Intended Use

This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system. 

Indications For Use

This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).  

Contraindications

This neurostimulation system is contraindicated for patients who are 

  • Unable to operate the system

  • Poor surgical risks 

Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure.

MRI Safety Information

Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. 

For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals). 

For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html

Warnings

The following warnings apply to this neurostimulation system.

Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.

Pediatric use. The safety and effectiveness of neurostimulation for pediatric use have not been established.

Back pain. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated.

External defibrillators. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. After defibrillation, confirm the neurostimulation system is still working.

Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients.

Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient.

Computed tomography (CT). If the patient requires a CT scan, all stimulation should be turned off before the procedure. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range.

  • For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should:

  • Determine the device type

  • If practical, try to move external devices out of the scan range 

  • Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. 

  • Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds.

Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur.

After CT scanning directly over the implanted or externally worn electronic medical device: 

  • Have the patient turn the device back on if it had been turned off prior to scanning.

  • Have the patient check the device for proper functioning, even if the device was turned off.

  • Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan.

Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. 

Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure.

During implant procedures, if electrosurgery devices must be used, take the following actions: 

  • Use bipolar electrosurgery only.

  • Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.

  • Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.

  • Set the electrosurgery device to the lowest possible energy setting.

  • Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. 

Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: 

  1. Maximize the distance between the implanted systems; 

  2. Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and 

  3. Avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system

Other active implantable devices. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown.

Radiofrequency or microwave ablation. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.

Emergency procedures. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion.

Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.

Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Restricted areas. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker.

Component manipulation by patients. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection.

Implantation at vertebral levels above T10. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated.

Number of leads implanted. The safety and efficacy of the implantation of greater than four leads have not been evaluated.

Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Excessive lead migration may require reoperation to replace the leads.

Scuba diving and hyperbaric chambers. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system.

Operation of machines, equipment, and vehicles. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 

However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others.

Explosive and flammable gasses. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of these devices could cause them to ignite, causing severe burns, injury, or death.

Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to avoid damage. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing.

Device components. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient.

Device modification. The equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.

Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (i.e., jailbroken).

Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.

Cremation. The IPG should be explanted before cremation because the IPG could explode. Return the explanted IPG to Abbott Medical.

IPG disposal. Return all explanted IPGs to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.

Product materials. Neurostimulation systems have materials that come in contact or may come in contact with tissue. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted.

Additional Warnings for Leads

Conscious sedation. The placement of the leads involves some risk, as with any surgical procedure. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Use caution when sedating the patient. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage.

Preventing infection. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Use appropriate sterile technique when implanting leads and the IPG.

Lead damage from tools. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead.

Needle positioning. Always be aware of the needle tip position. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures.

Needle insertion. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak.

Advancing components. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Advance the needle and guidewire slowly. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage.

Removing components. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Removing each item in slow movements while holding the remaining components in place will assist this process.

Sheath insertion warning. Insertion of a sheath without the lead may result in dural puncture. Securing the lead with the lead stabilizer will mitigate this risk.

Sheath retraction. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. Failure to do so may result in damage to the sheath. Before reinserting the sheath, verify there is no damage to the sheath.

Sheath rotation. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. The tip of the sheath may whip around and could cause harm to the patient.

Lead insertion through sheath. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Do not use excessive pressure when injecting through the sheath.

Removing a kinked sheath. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Failure to do so can damage or cut the lead or sheath. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath.

Providing strain relief. Failure to provide strain relief may result in lead migration requiring a revision procedure.

Anchoring leads. Do not suture directly onto the lead to avoid damaging the lead. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation.

Remove leads slowly. Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Always perform removal with the patient conscious and able to give feedback.

Precautions

The following precautions apply to this neurostimulation system.

General Precautions
  • Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.

  • Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.

  • Implantation of multiple leads. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.

  • High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations occur, the device should be turned off immediately.

  • Postural changes. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. However, some patients may experience a decrease or increase in the perceived level of stimulation. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting.

    Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. If unpleasant sensations occur, the IPG should be turned off immediately.

  • Advise patients about adverse effects. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components.

  • Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system.

  • Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient.

  • Battery precaution. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Do not crush, puncture, or burn these devices because explosion or fire may result. Return them to Abbott Medical for proper disposal.

  • Stimulation effectiveness. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. Stimulation effectiveness has been established for one year.

Sterilization and Storage
  • Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.

  • Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind. 

Handling and Implementation
  • Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.

  • Package or component damage. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Return any suspect components to Abbott Medical for evaluation.

  • Handle the device with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.

  • Lead inspection. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target.

  • Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

  • Component handling. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function.

  • Using surgical instruments. Do not use surgical instruments to handle the lead. The force of the instruments may damage the lead or stylet.

  • Using the tunneling tool. Use extreme care to not damage the lead with the sharp point of the tunneling tool.

  • Component manipulation. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space.

  • Stylet handling. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Use care when reinserting a stylet. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Remove the stylet from the lead only when satisfied with lead placement. If the stylet is removed from the lead, it may be difficult to reinsert it.

  • Sheath insertion precaution. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura.

  • Stabilizing the lead during insertion. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Failure to do so may cause harm to the patient such as damage to the dura.

  • Bending the sheath. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead.

  • Lead handling. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Failure to do so may result in difficulty delivering the lead.

  • Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation.

  • Inserting the anchor. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location.

  • Securing the anchor. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system.

  • Placing the IPG. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG.

  • Securing the IPG. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged.

  • System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.

  • Conscious sedation during removal. Always perform removal of implanted components with the patient conscious and able to give feedback.

  • Surgical advice for removal. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Consider seeking surgical advice if you cannot easily remove a lead.

  • Component disposal. Return all explanted components to Abbott Medical for safe disposal.  

Hospital and Medical Environments
  • High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.

  • Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.

  • Transcutaneous electrical nerve stimulation (TENS). Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician.

Home and Occupational Environments
  • Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: 

    • commercial electrical equipment (such as arc welders and induction furnaces) 

    • communication equipment (such as microwave transmitters and high-power amateur transmitters) 

    • high-voltage power lines 

    • radiofrequency identification (RFID) devices 

    • some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy) 

    • and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes)

  • Interference with wireless equipment. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG.

  • Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

  • Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation.

    Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation.

    Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Patients should cautiously approach such devices and should request help to bypass them. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly.

  • Overcommunicating with the IPG. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life.

  • Mobile phones. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system.

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: 

  • Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately.)

  • Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure or breakage

  • Stimulation in unwanted places (such as stimulation of the chest wall)

  • Lead migration, causing changes in stimulation or reduced pain relief

  • Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage

  • Tissue damage or nerve damage

  • Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant

  • Pain or bleeding where the needle was inserted

  • Persistent pain at the electrode or IPG site

  • Escalating pain

  • Seroma (mass or swelling) at the implant site

  • Headache

  • Allergic or rejection response to device or implant materials

  • Implant migration or skin erosion around the implant

  • Battery failure, leakage, or both

  • Hardware malfunction that requires replacing the neurostimulator

  • Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain

  • Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.)

Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. This may occur once the lead is in place and is connected to the neurostimulator and activated. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Additionally, all patients will be awake and conversant during the procedure to minimize the impact.

71376 MAT-2006974 v2.0 | Item approved for U.S. use only.

Deep Brain Stimulation (DBS) Therapy

Intended Use

This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.

Indications For Use

The Abbott Medical deep brain stimulation system is indicated for the following conditions:

  • Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications.
  • Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.

Contraindications

This system is contraindicated for patients who meet the following criteria:

  • Are unable to operate the system

  • Have unsuccessful test stimulation

The following procedures are contraindicated for patients with a deep brain stimulation system. Advise patients to inform their healthcare professional that they cannot undergo the following procedures:

  • Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy)

  • Electroshock therapy and transcranial magnetic stimulation (TMS)

MRI Safety Information

Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals). For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/MRI-ready.

Warnings

The following warnings apply to this neurostimulation system.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Patients should not use this neurostimulation system if they are pregnant or nursing.

Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients.

Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.

High stimulation outputs and charge density limits. Avoid excessive stimulation. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths.

High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. If the programming of stimulation parameters exceeds the charge density limit of 30 μC/cm2, a screen will appear warning you that the charge density is too high. Charge density can be reduced by lowering the stimulation amplitude or pulse width. For more information, see the clinician programmer manual.

Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet.

Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.

Risk of depression, suicidal ideations, and suicide. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Therefore, physicians should consider the following:

  • Preoperatively, assess patients for the risks of depression and suicide. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated.

  • Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control.

  • If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately.

  • Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider.

Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

Explosive or flammable gasses. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death.

Operation of machinery and equipment. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return.

Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.

Device components. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient.

Device modification. This equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service. 

Application modification. To prevent unintended stimulation, do not modify the generator software in any way. Only apply software updates that are published directly by Abbott Medical.

Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure.

During implant procedures, if electrosurgery devices must be used, take the following actions:

  • Use bipolar electrosurgery only.

  • Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.

  • Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.
  • Exit Surgery Mode during intraoperative testing and after the procedure is completed. NOTE: During intraoperative testing, Surgery Mode must be turned off for the neurostimulation system to function correctly.
  • Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.

After any surgery, check the neurostimulation system for the following:

  • Check the neurostimulator to ensure Surgery Mode has been turned off, even if Surgery Mode was not turned on at the beginning or during the procedure.
  • Confirm the neurostimulation system is functioning

Radiofrequency or microwave ablation. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.

Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system:

  1. Maximize the distance between the implanted systems; 

  2. Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and 

  3. Avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.

Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system.

Interference with other devices. Some of this system’s electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Avoid placing equipment components directly over other electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected.

Case damage. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals.

Cremation. The IPG should be explanted before cremation because the IPG could explode. Return the explanted IPG to Abbott Medical.

Generator disposal. Return all explanted components to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.

Product materials. Neurostimulation systems have materials that come in contact or may come in contact with tissue. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted.

Coagulopathies. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.

Low frequencies. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). For this reason, programming at frequencies less than 30 Hz is not recommended.

Return of symptoms and rebound effect. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). In rare cases, this can create a medical emergency.

Precautions

The following precautions apply to this neurostimulation system.

General Precautions

Surgeon training. Implanting physicians should be experienced in stereotactic and functional neurosurgery.

Clinician training. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used.

Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system

Patient selection. Select patients appropriately for deep brain stimulation. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen.

Especially consider the following additional factors when selecting patients:

  • Level of available support from a caregiver.

  • Expected effect from cessation of therapy, should disease symptoms return unexpectedly.

  • Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device.

  • Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance.

  • Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device.

  • Patient's visual ability to read the patient controller screen.

Infection. Follow proper infection control procedures. Infections may require that the device be explanted.

Implantation of two systems. If two systems are implanted, ensure that at least 20 cm (8 in.) separates the implanted generators to minimize unintended interaction with other system components.

Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.

Implant heating. While charging the generator, patients may perceive an increase in temperature at the generator site. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation.

Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: 

  • Commercial electrical equipment (such as arc welders and induction furnaces), 

  • Communication equipment (such as microwave transmitters and high-power amateur transmitters), 

  • High-voltage power lines, 

  • Radiofrequency identification (RFID) devices, 

  • And some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).

Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient.

Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. 

Patients should cautiously approach such devices and should request help to bypass them. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off.

Unauthorized changes to stimulation parameters. Caution patients to not make unauthorized changes to physician-established stimulation parameters.

Damage to shallow implants. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions.

Keep programmers and controllers dry. The clinician programmer and patient controller are not waterproof. Keep them dry to avoid damage. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing.

Handle the programmers and controllers with care. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.

Battery care. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire.

Long-term safety and effectiveness. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinson’s disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI.

Sterilization And Storage

Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.

Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind. Detailed information on storage environment is provided in the appendix of this manual.

Handling And Implantation

Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.

Recharge. Recharge information is printed on the packaging, which instructs the user to fully charge the generator before implantation.

Handle devices with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.

Care and handling of components. Use extreme care when handling system components. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

Package or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to Abbott Medical for evaluation.

Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation.

Skin erosion. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface.

System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.

Multiple leads. When multiple leads are implanted, route the lead extensions so the area between them is minimized. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI).

Abandoned leads and replacement leads. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown.

Placement of lead connection in neck. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture.

Hospital And Medical Environments

Electrical medical treatment. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment.

High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.

Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.

External defibrillators. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.

Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Electrocardiograms. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Inaccurate ECG results may lead to inappropriate treatment of the patient.

Home And Occupational Environments

Patient activities and environmental precautions. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves.

Control of the patient controller. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards.

Activities requiring excessive twisting or stretching. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component.

Activities requiring coordination. Loss of coordination is a potential side effect of DBS therapy. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming).

Bathing. Patients should exercise reasonable caution when bathing.

Component manipulation by patient. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation.

Scuba diving or hyperbaric chambers. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician.

Skydiving, skiing, or hiking in the mountains. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead.

Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

Consumer goods and electronic devices. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator however, it will not change the prescribed programmed parameters. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) away from the generator and avoid placing any smart device in a pocket near the generator. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support.

Household appliances. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off.

Therapeutic magnets. Patients should be advised to not use therapeutic magnets. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off.

Adverse Effects

Deep brain stimulation potentially has the following adverse effects:

Possible surgical complications. Surgical complications include, but are not limited to, the following: 

  • Intracranial hemorrhage (which can lead to stroke, paralysis, or death); 

  • Subcutaneous hemorrhage or seroma; 

  • Hematoma; 

  • Cerebrospinal fluid leakage or cerebrospinal fluid abnormality; 

  • Brain contusion; 

  • Infection or inflammation; 

  • Antibiotic anaphylaxis; 

  • Skin disorder; 

  • Edema; 

  • Persistent pain at surgery site or IPG site; 

  • Erosion; 

  • Brachial plexus injury (nerves to chest, shoulder and arm); 

  • Postoperative pain, stress, or discomfort; 

  • Neuropathy (nerve degeneration); 

  • Hemiparesis (muscular weakness or partial paralysis on one side of body); 

  • Ballism or hemiballism (uncontrollable movements on both or only one side of the body); 

  • Confusion—transient, nocturnal or ongoing; 

  • Cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; 

  • Aphasia; 

  • Deep vein thrombosis; 

  • Complications from anesthesia; 

  • Phlebitis (vein inflammation); 

  • Pulmonary embolism (sudden blood vessel obstruction); 

  • Aborted procedures (air embolism, unable to find target, surgical complication, etc.); 

  • Complications from unusual physiological variations in patients, including foreign body rejection phenomena; 

  • Pneumonia, seizure or convulsions; 

  • Paralysis (loss of motor function, inability to move); 

  • Stroke and death.

Possible deep brain stimulation complications. Deep brain stimulation complications include, but are not limited to, the following:

  • Device-related complications

    • Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture

    • Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension  fracture

    • Initial jolt or tingling during stimulation; jolting or shocking sensations

    • Infection

    • Paresthesia

    • Lead fracture, migration, or dislodgement

    • Misplaced lead

    • Extension malfunction, fracture, or disconnect

    • Deep brain stimulation system failure or battery failure within the device

    • Deep brain stimulation system malfunction or dislodgement

    • Spontaneous turning on or off of the IPG

    • Allergic or rejection response to implanted materials

    • Persistent pain, tightness, or redness at the incision sites or general pain

    • General erosion or local skin erosion over the IPG

    • Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck)

    • Impaired wound healing (e.g., incision site drainage) or abscess formation

    • Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component

  • Stimulation-related complications or other complications

    • Worsening of motor impairment and Parkinson’s disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia

    • Paresis, asthenia, hemiplegia, or hemiparesis

    • Dystonia

    • Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance

    • Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia

    • Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia,  delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep  disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium

    • Restless leg syndrome

    • Supranuclear gaze palsy

    • Hypersexuality or increased libido

    • Decreased therapeutic response

    • Urinary incontinence or retention

    • Diarrhea or constipation

    • Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope)

    • Difficulty breathing

    • Increased salivation

    • Weight gain or loss

    • Eye disorder including eye apraxia or blepharospasm

    • Nausea or vomiting

    • Sweating

    • Fever

    • Hiccups

    • Cough

    • Cramps

    • Worsening existing medical conditions

23-86540 MAT-2215217 v3.0 | Item approved for U.S. use only.

IonicRF™ Generator

Prescription And Safety Information

Read this section to gather important prescription and safety information.

Intended Use

The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is intended for lesioning of neural tissue in the nervous system as an aid in the management of pain. 

Indications For Use

The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is indicated as an aid in the management of pain in the nervous system. Examples include facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures.

Contraindications 

The use of this device is contraindicated in patients with systemic infection or local infection in the area of the procedure.

Warnings 

The following warnings apply to this generator.

Instructions for use. Read and understand the instructions for use provided in this clinician's manual before operating the generator. 

Hazardous electrical output. The generator is for use only by qualified medical personnel. 

Electric shock hazard. This device presents an electric shock hazard under certain conditions. Physicians need to be aware of the following warnings: 

  • To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 

  • Only approved medical grade power cords can be used with the generator. Use only the power cord specified for this unit. No modification of this equipment is allowed. 

  • Do not attempt to service or modify the equipment. For service, contact Abbott Medical. 

  • Do not under any circumstances perform testing or maintenance on the equipment while it is being used on a patient. 

  • Replace the power cord or plug immediately if it is cracked, frayed, broken, or otherwise damaged. 

  • Turn off the equipment and unplug the power cord before cleaning or servicing. 

  • Do not allow any fluid to enter the ventilation holes or sockets. 

Equipment failure. A failure of the equipment could result in an unintended increase of output power. If unexpected parameters are observed that do not correspond to the preset values, halt the procedure immediately by pressing the Emergency Stop button on the top of the generator. Do not operate the equipment again until the source of the problem is identified and corrected. 

Explosion hazard. Do not use this equipment in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. 

Fire hazard. This device presents a fire hazard under certain conditions. Physicians need to be aware of the following warnings: 

  • Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged. 

  • Use recommended non-flammable agents for cleaning and disinfection whenever possible. See “Cleaning the Generator” (page 32). 

  • Flammable agents for cleaning, disinfecting, or as solvents of adhesives must be allowed to evaporate before using radiofrequency (RF) surgery.

  • Do not place electrodes near or in contact with flammable materials.

Pooling hazard. Flammable solutions may pool under the patient or in body depressions, such as the umbilicus, and in body cavities, such as the vagina. Remove fluids pooled in body depressions and cavities before using the generator. 

Ignition hazard. Be aware of and take care to avoid the danger of ignition of endogenous gasses (e.g., cotton and gauze saturated with oxygen may be ignited by sparks produced during normal use of the generator).

Risk of RF burns and unintended stimulation. Do not turn the generator power on while touching any electrodes or probes. Do not place a generator-connected electrode that is not being used in contact with the patient. 

Risk of RF burns to patient. This device presents a risk of RF burns to the patient under certain conditions. Physicians need to be aware of the following warnings: 

  • Ensure the patient does not come into contact with metal parts of the table and its accessories. Antistatic sheeting is recommended. 

  • Avoid skin-to-skin contact between different parts of patient’s body (for example between the arms and the body of the patient). Use dry gauze if necessary. 

  • Avoid using physiological monitoring equipment during a procedure. If monitoring is required, place monitoring electrodes as far as possible from the electrode. Monitoring devices that use needle electrodes are not recommended. In all cases, monitoring systems with high-frequency current limiting devices are recommended.

  • Connection of a patient to high-frequency surgical equipment and to electromyograph or evoked response equipment simultaneously may result in burns at the site of the electrodes and possible damage to the applied parts.

  • Position all cables to the electrode and grounding pad (also known as the return electrode, dispersive electrode, or neutral electrode) to avoid contact with other electrodes and other metal objects. 

  • Place temporarily unused electrodes connected to the generator in a container or area that is electrically isolated from the patient. Never place a generator-connected electrode that is not being used in contact with the patient. When not in use, place accessories in a clean, dry, highly visible area away from patient contact.

  • When not in use, place accessories in a clean, dry, highly visible area away from patient contact.

  • Only use grounding pads listed in the Accessories section of this manual. See "Appendix B: System Components and Accessories" (page 1). 

  • When positioning the grounding pad, select a well-vascularized muscular site with proximity to the procedure. See "Applying the Grounding Pad" (page 20). 

  • Place the long side of the grounding pad perpendicular to the direction of the current flow from the operative site. See "Applying the Grounding Pad" (page 20).

  • Do not place the grounding pad over scars, bony prominences, prostheses, hair, or EKG electrodes.

  • Do not place the grounding pad in a location where fluids may pool.

  • If the patient is sedated, place your hand on the backside of the grounding pad, while still leaving it attached to the patient. If the grounding pad is unreasonably hot (a temperature greater than 46°C), stop the procedure by pressing the Emergency Stop button.

  • If the patient complains of heating at the grounding pad site, stop the procedure and remove the grounding pad from the patient.

  • Before applying power to the electrodes, ensure that the entire area of the grounding pad is firmly adhered to a suitably prepared and appropriate area of the patient’s body as defined in the grounding pad instructions for use.

  • If the continuity monitor alarm is triggered, remove and discard the grounding pad. Place a new grounding pad on a fresh patch of skin.

  • If unexpected parameter readings are observed that do not correspond to the preset values, halt the procedure immediately by pressing the Emergency Stop button. Do not operate the equipment again until the source of the problem is identified and corrected.

Interference with active implants. Check whether the patient has a cardiac pacemaker or other active implantable device and, if so, obtain qualified advice before using the generator. Operating the generator may interfere with or damage the implanted device. 

Redirection of high-frequency currents. Check whether the patient has an electrically conductive implant and, if so, obtain qualified advice before using the generator. Operating the generator may cause concentration or redirection of high-frequency currents. 

Interference with other equipment. During RF lesioning procedures, the radiated electrical fields may interfere with other electrical medical equipment. See "Minimizing Electromagnetic Interference" (page 5). 

Shortwave or microwave equipment. Operation in close proximity to shortwave or microwave therapy equipment may produce instability in the applied parts. 

Apparent low output or failure of equipment. If low output is observed or the equipment does not function correctly at normal operating setting, check the grounding pad and its connections. 

Risk of patient injury. Do not use endoscopically. The accessories are not appropriate for endoscopic use. 

Proper device use. Do not operate the generator if the alert tones are not audible after the volume is adjusted. 

Non-sterile. The generator is non-sterile and should be kept outside of the sterile field. 

Accessories. Use only accessories approved by Abbott Medical. See “Appendix B: System Components and Accessories” (page 40). 

Continuity monitoring. The generator uses continuity monitoring. Loss of full contact between the neutral electrode and the patient will result in an auditory alarm.

Precautions 

The following precautions apply to this generator. 

Inspection. Inspect the generator and reusable accessories before each use. In particular, check the electrode cable insulation for possible damage. 

Mechanical damage. If the equipment has suffered any mechanical damage, return it to the supplier for inspection and testing before further use. 

Electrode positioning. Do not activate the generator output until the electrodes are correctly positioned in the patient. 

Use of fluids. If fluids are being used during a procedure, ensure that they are positioned away from the generator. 

Dispersive connections. Ensure that the grounding pad is connected to the patient and to the generator. 

Cleaning the generator. When cleaning the outer casing or touchscreen, do not use abrasive agents or solvents. See "Cleaning the Generator" (page 32). 

Emergency stop. For safety, always have someone positioned next to the Emergency Stop button during operation. If at any time the device is behaving erratically, press the Emergency Stop button, located on top of the generator, which will return the device to a safe state. For example, if the displayed temperature and graph do not match the desired set temperature.

Adverse Events 

Possible adverse events that may result from the use of this device include, but are not limited to, the following: 

  • As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury can occur. 

  • Nerve injury, including thermal injury, or puncture of the spinal cord or nerve roots, potentially resulting in radiculopathy, paresis, and paralysis. 

  • Pain, pulmonary embolism, hemothorax or pneumothorax, infection, unintended puncture wound, including vascular puncture and dural tear, hemorrhage, and hematoma.

71391 MAT-2006978 v2.0 | Item approved for U.S. use only.

Simplicity™ III Disposable Radiofrequency Electrode

Prescription And Safety Information

Read this section to gather important prescription and safety information.

Indications For Use

The Abbott Medical Simplicity™ III Disposable Radiofrequency Electrode is intended for use in the treatment of chronic pain by the ablation of neural tissue.

Description

The Simplicity III electrode is a disposable radiofrequency (RF) device consisting of three isolated electrodes along the shaft. Radiopaque markers are located between the distal and the middle electrodes, between the middle and the proximal electrodes, and below the proximal electrode. These radiopaque markers clearly show the separation of the three electrodes under X-ray. The Simplicity III electrode needs to be connected to an Abbott Medical RF generator using an Abbott Medical adapter cable.

Warnings

  • Sharp; handle carefully.
  • Do not proceed unless all electrodes read body temperature when connected and inserted into the patient.
  • Stop if heat is felt at site of the grounding pad.
  • When the Simplicity III electrode is used to perform lesion procedures in the sacral region, always ensure that the electrode does not enter any of the sacral foramen and that the electrode does not proceed inferior to the inferior border of the sacrum.
  • Do not use the electrode if the package has been opened or damaged.
  • Ensure the most proximal contact on the electrode is not too close to the dermis to prevent skin burn.
  • Use of general anesthesia is not recommended during the procedure. It is advised to use local anesthesia or conscious sedation so patient interaction is possible.
  • The electrode should only be used by physicians trained in the use of the device.
  • The electrode is intended for single-use only. This device is not intended for bilateral use.
  • The electrode should only be used with an Abbott Medical RF generator.
  • During treatment with the Simplicity III electrode, the patient should continuously be monitored and evaluated for any unexpected symptoms.
  • Before starting any thermal treatment with the electrode, ensure no motor nerves are in the vicinity of the electrode.
  • Do not move the electrode while it is activated.
  • Do not use the electrode if any damage is observed.
  • Do not bend or reshape the electrode; this can cause permanent mechanical damage.
  • Use minimal force and torque when manipulating the electrode; the handle has been designed to release if too much torque is applied. 
  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
  • Reprocessing may compromise the structural integrity of the device and/or lead to device failure.
  • Cleaning, disinfection, and sterilization may compromise essential material and design characteristics, leading to device failure.

71398 MAT-2006979 v2.0 | Item approved for U.S. use only.

MR Conditional Systems

MR Conditional SCS/DRG Systems

The following warnings, precautions, and potential adverse events apply when performing MRI scans on Abbott MR Conditional SCS/DRG systems.

Warnings

Unapproved components. Do not perform an MRI scan on patients who have any components of a neurostimulation system that are unapproved for use in an MR environment. Serious patient injury could occur. 

Abandoned devices. Do not perform an MRI scan on patients who have an incomplete neurostimulation system, where a lead is present without the IPG or disconnected from the system. Serious patient injury could occur. 

Nonfunctional leads. Do not perform an MRI scan on patients when the “MRI is Not Advised. There may be a problem with the implanted lead(s)” message displays when attempting to enter MRI mode on the patient controller. MRI scans of nonfunctional leads may result in excessive heating occurring at the location of the implanted lead electrodes and serious patient injury. 

Location of implanted system. To meet the MR Conditional requirements, components must be implanted according to the approved locations specified by the MRI labeling. The MR Conditional leads must be implanted in the epidural space and routed subcutaneously to the IPG pocket. Two leads should travel in close proximity to one another from the IPG to the spine. Lead tips can be located at different spinal epidural levels. MRI scans of implants that are not located in approved locations can possibly result in increased unintended stimulation, excessive heating at the lead electrodes, and serious patient injury.

Location of RF transmit-receive coils [Select systems only, refer to the MR Procedure Information to determine applicability]. Head or extremity MRI scans can be conducted safely using a Detachable Head or Extremity RF transmit-receive coil when no parts of the implanted neurostimulation system are within the transmit-receive coil according to the conditions specified for each system in the MRI labeling. This can be confirmed with X-ray imaging of the neck, head, and extremity regions or by referring to the patient records. 

Skin erosion. Do not perform an MRI scan on patients who have any portion of their implanted system exposed due to skin erosion. The MRI scan may result in excessive heating of the system and serious patient injury. 

Neurostimulation trial systems. Do not perform an MRI scan on patients who have an external neurostimulation trial system or any components that are not fully implanted. Serious patient injury could occur. 

Multiple neurostimulation systems. Do not perform an MRI scan on patients who have multiple MR Conditional neurostimulation systems for pain (multiple IPGs for pain). MRI scans may result in excessive heating of the lead electrodes and serious patient injury. 

Other implanted medical devices. Prior to an MRI examination, determine whether the patient has multiple medical device implants, either active medical device implants (such as deep brain stimulation systems, implantable cardiac defibrillators, pacemakers) or passive medical device implants (such as spinal hardware, stents). Of all medical device implants, the most restrictive MRI exposure requirements must be used. Do not conduct an MRI scan if any conditions or implants prohibit it, as serious patient injury could occur. If you are unclear what implants are present, perform an X‑ray to determine the implant type and location. 

Imaging with atoms other than hydrogen. Do not conduct MRI scans with nonproton scanning frequencies (such as 13C, 23Na, or 31P). Frequencies other than 64 MHz could cause device damage, excessive heating, and serious patient injury. 

MRI system type. Only use 1.5T cylindrical-bore magnet, horizontal field-orientation MRI systems. Do not scan with other MRI systems, such as 1.0T and 3.0T machines or vertical field orientation machines, as device damage, excessive heating of implanted components, and serious patient injury could occur. 

Patient position. Do not scan with the patient in any prone positions or “superman” positions (where the patient's arm is raised above his or her head). Use of these positions could cause device damage and excessive heating of implanted components, which could result in serious patient injury.

Operating mode. Do not conduct MRI scans in first-level controlled or second-level controlled operating mode. These modes allow higher levels of RF energy and may cause excessive heating of implanted components, which could result in serious patient injury.

SAR or B1+rms limits. For scans requiring maximum SAR <2 W/kg or specific maximum B1+rms value, personnel knowledgeable in MR safety should be involved to optimally plan the scan and actively monitor SAR or B1+rms levels during the scan. Ensure the scanner displays the SAR or B1+rms value prior to starting the scan. Exceeding the SAR or B1+rms limits may cause excessive heating of implanted components, which could result in serious patient injury.

Transmit coils. Only use circularly polarized transmit coil designs. Do not scan with other transmit coil designs (for example, linear, phased-array, or saddle) as serious patient injury could occur.

Active scan time. The total active scan time must be limited to 30 minutes per session with a wait time of 30 minutes between sessions. Exceeding the active scan time limit increases the risk of excessive heating and serious patient injury.

Fever. Before an MRI scan, determine the patient's body temperature. If the patient has a fever, do not perform an MRI scan. The MR Conditional evaluation has been performed for patients with a typical body temperature of 37°C (98.6°F). Elevated body temperature in conjunction with tissue heating caused by the MRI scan could result in excessive heating of implanted components and serious patient injury.

MRI Mode patient instructions. A paired patient controller or clinician programmer is required to disable MRI Mode. The inability to disable MRI Mode would require device replacement surgery to restore therapy. Provide the following instructions to patients:

Prior to enabling MRI Mode

  • Upgrade their patient controller to the latest Patient Controller app from the app store.
  • Disable automatic updates for the patient controller app and the device operating system software (such as Apple‡ iOS‡).
  • Do not enable MRI Mode more than 24 hours prior to the MRI scan. 

While in MRI Mode

  • Do not alter, damage, update or lose their patient controller while in MRI Mode.
  • Do not update, install or delete the patient controller app while in MRI Mode.
  • Do not delete the pairing between the IPG and the patient controller or delete the IPG from the Generators list while in MRI Mode.
  • Do not update the device operating system while in MRI Mode.

Disabling MRI Mode. An inability to disable MRI Mode will occur if the patient controller is no longer paired to the IPG and there is no previously paired clinician programmer available or if the clinician programmer lost its Bluetooth® wireless connection pairing to the IPG. The inability to disable MRI Mode would require device replacement surgery to restore therapy.

Precautions

External devices. Do not allow external control devices into the scanner magnet room, such as a programmer, controller or charging system. Because these devices contain ferromagnetic material, they can be affected by the MRI magnet, may present a projectile hazard and are considered MR Unsafe.

Electromagnetic interference (EMI). Some electrical equipment, such as an MRI machine, may generate enough EMI to interfere with the operation of the internal or external electronic components of a neurostimulation system if the equipment is too close to the system component. To mitigate the effects of possible EMI, increase the distance between the electrical equipment and the system component that is affected and try performing the operation again.

Potential Adverse Events

  • Lead electrode heating resulting in patient discomfort, tissue damage or serious patient injury 

  • IPG heating resulting in tissue damage in the implant pocket or patient discomfort or both 

  • Induced currents on leads resulting in overstimulation or shocking sensations 

  • Damage to the IPG or leads causing the system to fail to deliver stimulation or causing the system to deliver overstimulation 

  • Damage to the functionality or mechanical integrity of the IPG resulting in the inability to communicate with the IPG 

  • Movement or vibration of the IPG or leads

 

MR Conditional DBS Systems

The following warnings, precautions and potential adverse events apply when performing MRI scans on Abbott MR Conditional DBS systems. 

Warnings

Unapproved components. Do not perform an MRI scan on patients who have any components of a neurostimulation system that are unapproved for use in an MR environment.

Abandoned devices. Do not perform an MRI scan on patients who have any abandoned neurostimulation devices, such as an implantable pulse generator (IPG), lead, extension or adapter.

Nonfunctional leads or extensions. Do not perform an MRI scan on patients with broken or intermittent MR Conditional leads or extensions, or impedance measurements not within the impedance limits. MRI scans of patients with nonfunctional leads may result in higher than normal heating occurring at the location of the implanted lead electrodes.

Location of implanted system. To meet the MR Conditional requirements, components must be implanted according to the approved locations specified by the MRI labeling. Implant location can be confirmed with X-ray imaging or by referring to the patient records. The MR Conditional leads and extensions must be fully implanted under the skin and routed on the same side of the body as the IPG pocket.

Routing multiple leads and extensions to the same IPG. If multiple MR Conditional leads and extensions are routed to the same IPG, they should be routed in close proximity on the same side of the body as the IPG. Nonadjacent leads and extensions can result in increased unintended stimulation or heating at the lead electrodes.

Partially implanted or exposed components. Do not perform an MRI scan on patients who have any portion of their system exposed due to partial implantation or skin erosion. The MRI scan may cause heating of the system, which could result in serious patient injury.

Multiple neurostimulation systems. If a patient is implanted with two DBS IPGs, ensure that both IPGs are set to MRI mode before scanning. If a patient is implanted with one lead-only system and one full system, follow the more restrictive MRI scanning requirements of the systems, and ensure that the IPG is set to MRI mode before scanning.

Other implanted medical devices. Scanning patients who have other MR Conditional devices is acceptable as long as all the MR Conditional requirements for each of the implanted devices are met. Do not conduct an MRI scan if any conditions or implants prohibit it. If you are unclear what implants are present, perform an X‑ray to determine the implant type and location.

Imaging with atoms other than hydrogen. Imaging with atoms other than hydrogen has not been tested and could result in serious patient injury.

Patient body temperature. Before an MRI scan, determine the patient's body temperature. If the patient has a fever, you should not perform an MRI scan.

Precautions

External devices. Do not allow external control devices, such as a patient controller or clinician programmer, into the scanner magnet room. Because these devices contain ferromagnetic material, they can be affected by the MRI magnet, may present a projectile hazard, and are considered MR Unsafe.

Electromagnetic interference (EMI). Some electrical equipment, such as an MRI machine, may generate enough EMI to interfere with the operation of the internal or external electronic components of a neurostimulation system if the equipment is too close to the system component. To mitigate the effects of possible EMI, increase the distance between the electrical equipment and the system component that is affected and try performing the operation again.

Turning off stimulation before a scan. When you set a full system into MRI mode, stimulation turns off. Carefully consider a patient’s underlying medical condition and disease symptoms before turning off a neurostimulation system when performing an MRI scan. Consult with the appropriate medical professional, such as a patient’s DBS managing clinician, to determine if it is safe to turn off stimulation to conduct an MRI scan. Do not conduct an MRI scan if stimulation needs to stay on.

Potential Adverse Events

  • Lead electrode heating resulting in tissue damage or serious patient injury

  • IPG heating resulting in tissue damage in the implant pocket or patient discomfort or both

  • Induced currents on leads resulting in unpleasant sensations or motor disturbances

  • Damage to the IPGs, leads or extensions causing the system to fail to deliver stimulation or causing the system to deliver overstimulation

  • Damage to the functionality or mechanical integrity of the IPG resulting in the inability to communicate with the IPG

  • Movement or vibration of the IPGs, leads or extensions

 

23-86498 MAT-2305130 v2.0 | Item approved for U.S. use only.