"That feels good."
With that seemingly simple affirmation, immediately following the seemingly simple activation of the Infinity Deep Brain Stimulation System (DBS), Jim McNasby felt the tremors – that had steadily worsened in the 19 years since he was diagnosed with Parkinson's disease – diminish.
Within 15 minutes, the attorney, who would lose his balance standing still on the street and felt nervous walking to his New York City office, was "running down the hall."
He was certainly not cured - there is no cure for Parkinson's, a degenerative neurological disorder - but he was on a path back to a world he sorely missed. "It's such a relief. When you have Parkinson's, the mundane becomes complicated and when I got Abbott's Infinity DBS, the mundane returned to mundane."
Jim's story is one of science and love and how a life can be transformed with a well-timed phone call from Massachusetts and some well-placed electrodes in the brain.
When Spilling Coffee is More than Spilling Coffee
Jim McNasby's life at 30 was something from the finale of a happy-ending comedy or the opening scene of a story that was going to get much worse before it could get better. He was a Harvard Law graduate, employed by the world's leading insurance broker and risk advisor, doing work that would eventually lead him to hold the title of General Counsel for 10 years.
He was traveling frequently and living in various locations around the world, when one day he spilled coffee on his shirt. The cup seemed to jerk in his hand. It was strange, but not a big deal. Until the next day when it happened again.
In retrospect, he realized that he had experienced other symptoms, like slight tremors, going back a couple of years but knew nothing about Parkinson's and hadn't thought too much of it. But this was different. He went to the doctor and was diagnosed in October 2000. He began taking medication in 2001 which kept things somewhat under control.
For a time.
Trending Over Time
Parkinson's, like many other conditions, has both a short- and long-term component. Individual days can be better than others, but over time, the condition will tend to trend downward, especially if the medication used to treat it loses some effectiveness over time (McNasby was taking 27 pills per day by the time he had his DBS activated).
As symptoms worsened over time, McNasby came to understand that one of the most powerful tools in his fight against the disease was his openness and sense of humor. "At first, I tried to hide the tremors because, especially in professional settings, you don't want that to be the focus of a meeting. But I soon came to realize that when I said I had Parkinson's, it allowed people to get past it quicker and created a better atmosphere."
Chopsticks and a Lazy Susan
"One time I had to fly to Taiwan for work. Long flights play havoc with the condition, as do interruptions in sleep patterns, medications and other things. By the time I arrived at the office, I was in pretty bad shape. Lunch was being served. With food situated on a Lazy Susan in the middle of a table and chopsticks as the only utensils, this was a nightmare for someone with Parkinson's, especially given that tremors were worse the further my arms extended from my body.
"I decided to just say I had Parkinson's upfront and the anxiety dissipated. One person quietly brought me utensils, another brought the food closer and what could've been an uncomfortable situation ended up leading to a really friendly, nice tone for the rest of our time together."
Mr. Tambourine Man
McNasby also found that the more he could make people laugh, the easier it was to talk about, and deal with, the condition. "I was speaking to a conference of attorneys when I fell from my chair. But when I got up, looked at the chair as if it was responsible and asked, 'Is there a lawyer in the house?' it made everyone laugh and much more comfortable."
And McNasby is all about increasing the comfort level during tough times. "I was talking to a man who'd just been diagnosed and he was, of course, nervous about the impact it would have on his life. We were talking about the adjustments that people have to make, and I told him, 'I can't write very well but I play a mean tambourine.' That's kind of my motto: Relax. Live in the moment. Play the tambourine."
Combination of Man and Machine
McNasby appears to give equal credit for his ability to enjoy his current life to the Infinity DBS and his husband, Donny Moss. Donny, who produces animal rights videos and runs associated campaigns, began dating McNasby in 2004, well after he had been diagnosed. "You don't make a conscious decision to bond or not with a person who has Parkinson's. We were just going on dates at first and then we were partners."
Moss, however, had no illusions about the disease. "I grew up in Miami Beach surrounded by an older population that included a lot of Parkinson's patients. I was very familiar with it. At the time, Jim's symptoms weren't as bad as people who contract it when they are older, but they did get a lot worse."
Unlike when the Infinity DBS was turned on with its immediate favorable impact, the progression of the Parkinson's was an evolution. "It started with Jim asking me to crack his back or extend his leg and over time, the need for help increased. It was difficult for him to do a lot of things he'd done before, like type or even go for a walk."
McNasby remembered how his husband helped care for him in a thousand small, wordless ways. "I got up earlier for my workday than Donny did for his, but when I was putting my shirt on, he was always standing there, ready to button the buttons, put on the cufflinks and tie my tie."
A Call from Massachusetts
As McNasby's symptoms progressed, Moss was increasingly involved in his care and treatment, even traveling to Boston to join a focus group made up of people caring for Parkinson's patients. Sponsored by a company that developed pharmaceuticals to treat the disease, discussions focused on needs, treatments and more. And the people who provided support and care had a lot to talk about.
"We had talked with my doctor about DBS years earlier," McNasby recalled. "But our feeling at that time was that it was brain surgery, which was scary to me and the medicine was working okay…until it wasn't. But in the intervening years, my symptoms had gotten worse.
"Donny called me after the focus group and said, 'Everyone here was asking me why you hadn't looked into DBS, because of your circumstances,'" McNasby said. "He knew that I'd thought about it a while back but I was on the 'not for me' track. But this call was different. I thought, 'I guess I should.'"
Hitting the Switch
"It was like a switch went off in his head," said Moss, foreshadowing the activation of the Infinity DBS. "He was going to get it. The decision was made right then."
As president of the Parkinson's Unity Walk, McNasby had an extensive network, called the executive director and told her he wanted DBS. She gave him the name of her doctor, who did a full assessment, and about three months after the Massachusetts call, he had the first of the three required procedures. After a four-week recovery, he went to the office to have the Infinity DBS activated.
Fifteen minutes later he was doing that hallway run.
What Happens After Infinity?
In McNasby's case, post-activation was wonderfully anti-climactic. Prior to the DBS, he had volunteered one day a week at the Michael J. Fox Foundation for Parkinson's Research. In March, 2020 he took on the full-time responsibilities of General Counsel and Chief People Officer there, the only full-time employee with the condition. "I represent the community," he laughs. On his first day at the office, it was closed due to COVID-19.
He has been through too much to let something like that get to him. He is grateful for all the days post-Infinity.
"Things returned to a kind of normal. I can use the cash machine and it doesn't take several minutes of feeling nervous and self-conscious. I used to be worried about everything, all day. I had to plan everything out and anticipate what might go wrong and how I'd adjust to it.
"It's freed up my mind, as well as my body. I don't have to waste brain power on routine things. I can spend it on accomplishing more, focusing on everything - and everyone - I want to focus on."
Not surprisingly, that everyone includes his husband. "When you get Parkinson's your entire support system gets it too," said McNasby. The couple has clearly felt each other's pain and relief.
"Even at his worst, Jim's Parkinson's has never stopped him from living," said Moss. "But it did compromise his quality of life. He did the things he liked but it could be so difficult and limiting. It wasn't until after the DBS that I realized how many of my decisions were impacted by how they could affect Jim. I can be away from home now, visiting my parents for a week and not worry if he will be ok."
The Infinity DBS has alleviated many of Jim McNasby's physical limitations. In doing so, it has increased the physical and emotional freedom for both he and his husband. If you asked Donny Moss how that feels, he'd probably say:
"That feels good."
IMPORTANT SAFETY INFORMATION
DEEP BRAIN STIMULATION (DBS) 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
United States:
The neurostimulation system is indicated for the following conditions:
International:
The neurostimulation system is indicated for the following conditions:
Contraindications
United States:
This system is contraindicated for patients who meet the following criteria:
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:
International:
Implantation of this neurostimulation system is contraindicated for the following:
The following procedures are contraindicated for patients that have been implanted with this device:
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 can cause tissue damage at the location of the implanted electrodes, resulting in a 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 replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment.
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. Scanning under different conditions may cause device malfunction, severe patient injury, or death. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS 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.
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.
If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. If a system does not meet the MR Conditional requirements, consider it MR Unsafe.
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.
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:
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.
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.
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:
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:
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.
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.
Component 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.
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.
IPG placement. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller.
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 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:
Infection. Follow proper infection control procedures. Infections may require that the device be explanted.
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:
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.
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.
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.
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.)
Mobile phones. The effect of mobile phones on deep brain stimulation is unknown. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. If interference occurs, try holding the phone to the other ear or turning off the phone.
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:
Possible deep brain stimulation complications. Deep brain stimulation complications include, but are not limited to, the following:
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.
72784 MAT-2215217 v2.0 | Item approved for U.S. use only.
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