Fact is, the Daniel Newman you're going to meet today — the one living the life he wants with the help of DRG stimulation to ease his pain — is just this version of the man.
Because the 1999 edition of Daniel Newman — the one who had a cervical fusion after "years of playing sports" — is not the same man in 2008, is not the same in 2020 and certainly not the same Daniel Newman today.
So you're not alone if you haven’t known any — let alone all — of the Daniel Newmans. In a lot of ways, neither have his young kids. And, frankly, even he has had times where he wasn't sure who he'd become and what the future might hold for the next edition of himself.
That is the power of chronic pain, a gravity so strong it bends realities and the people in them.
CRPS: The Beast
Newman lives with complex regional pain syndrome (CRPS). It started in his right hand in 2008 — "It felt like somebody had replaced my blood with gasoline and lit my hand on fire," Newman said — and now reaches through his legs right down to his toes.
Newman was familiar with the usual bumps and bruises that come from being athletic and playing sports. "Playing hockey for some time, I can deal with pain. I’ll get past it."
CRPS is something else altogether.
"There is no getting past CRPS. It's not like a broken bone that heals. CRPS is a nasty beast. It takes over everything."
Newman's beast was released in 2008.
Following graduate school at Syracuse and a decade as a therapist helping others with their mental and emotional pain, Newman had made a career switch to information technology. One fateful day, while servicing a client's IT network, he was carrying a load down a flight of stairs. He slipped on a child's toy that had been left behind.
"I cracked my head open. I popped my shoulder out," Newman said. "My body was a wreck."
About six months after his fall, he felt numbness, tingling and pain in his right arm. He was diagnosed with thoracic outlet syndrome (TOS).
Surgery removed muscles in his right chest area and under his armpit.
It did not take away his CRPS.
"Between 2008 and 2010-ish, I'd gone from never experiencing anything like that" to being unable to experience anything else. "I'll never forget: I was in physical therapy," Newman said. "They wanted me to move my hand back and forth. After about 30 seconds, I fell to the ground in horrific pain. CRPS."
Finally: Real, Lasting Relief
Newman said he tried "everything under the sun" to battle his CRPS.
Physical therapy. Opioids. Nerve blocks.
He was "still trying to function a little bit, still not trying to ignore life," but CRPS's gravity pulled every piece of his life to its will.
"When CRPS was at its worst, my life wasn't a life," Newman said. "I had a very dulled out sense of who I was. I was spending a lot of time on a couch, not being able to enjoy anything. Pain fully takes over your life. I didn't see hope. Very lonely and painful existence."
A reprieve came with his first Abbott spinal cord stimulator. The pain from his upper body injury — as only a hockey player would describe it — was better controlled.
That was until an operation on his knee opened his lower body to the beast.
"It started to spread everywhere. It got to be way too much for just the upper stim to handle," Newman said. "The feet are the worst part of it. With your hands, you can kind of limit what you're doing. With your feet, unless you learn to walk on your hands, you've got to use your feet all the time."
His upper stimulator just didn't have reach to touch his toes. That's where our Proclaim dorsal root ganglion (DRG) therapy is designed to manage difficult-to-treat chronic pain in his lower extremities due to CRPS.
Now, Newman can better control his pain by controlling both his upper and DRG stimulators though NeuroSphere Virtual Clinic via an app on his iPod mini.
"With the adjustments, you can find relief," Newman said. "My foot is at a certain number, my ankle is at a certain number, my hand is at a certain number. The great thing with the remote care is they can just log in to me — which is really cool — and help to adjust it. They take a look, talk to me while they're doing it and then relief is pretty immediate.
"That's the great thing with this device is that you can go from a 10 to a 3. It's never fully gone, especially the toes. The toes are very difficult. But to go from a 10 to a 3, it is livable."
And enjoyable. When we caught up Newman, he was about to hit the road for a Phish concert with his 6-year-old. His kids — both under 12 — have never known their dad without his CRPS. For all the intensity of his pain, the idea that his children would only see him that way may have weighed the heaviest. With his Proclaim DRG stimulator, Newman can be the father he wants to be.
The idea of it makes him smile. And laugh.
"They can beat on me," he said with a chuckle. "They expect me to be out in the backyard playing with them, taking them to the park. I don't see the concern in their eyes. You can't hide this from people. Sometimes I would just fall to the ground in excruciating pain. To be able to see my kids not feel what I'm feeling, that’s the greatest gift.
"It's nice to be that Superman and not the guy lying in a hospital bed," Newman said.
This is the Daniel Newman his kids — and the world — knows now.
He's no longer the guy who, at the depths of his CRPS when it hurt too much, sold off his beloved collection of Air Jordan shoes. It hurt too much to walk in them then.
He's a guy who's living his life, making his way to concerts and, yes, rebuilding his collection with fresh kicks. Every edition of Dan Newman always loved those shoes. "1s are always No. 1, just simply because there will never be the impact the way 1s impacted. 3s and 4s are little bit more comfortable. I do love the 11s too. Love the black patent (leather) on them. The 5s are cool. The 1s are obviously the coolest."
He's got that joy back.
"They have this tug on you. Great buying my first pair after DRG. I can't wear them like I used to wear them, but I can still wear them. So that's a big win."
Breaking Gravity’s Grasp
As a therapist, that Daniel Newman was a man who understood that the pain felt by others was real. His faith, sympathy and empathy were just as real. Seeing wasn’t necessary to believing.
As an IT expert, that Daniel Newman is a man who understands connections and how electrical signals can get mixed up. When the network is off, nothing works as it should. And where that causes figurative pain in an office, it can cause real pain in a person.
This Daniel Newman — the one soon to hit the road for a weekend of shows, anxious to reach the fresh grass tickling his toes from his lawn seats — has a message for those living with CRPS:
The pain is real. The signals can get mixed up. And as he's found relief, you can too.
That is his antigravity.
He's floating out the door now. Walking again like he always wanted: On air.
This is the experience of one person. Individual experiences, symptoms, situations and results may vary. The placement of a neurostimulation system requires surgery, which exposes patients to certain risks. Complications such as infection, swelling, bruising and possibly the loss of strength or use in an affected limb or muscle group (e.g. paralysis) are possible. Additional risks such as undesirable changes in stimulation may occur over time. Be sure to talk to your doctor about the possible risks associated with neurostimulation.
IMPORTANT SAFETY INFORMATION
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
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 sjm.com/MRIReady.
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.
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:
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:
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 gases. 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
Sterilization and Storage
Handling and Implementation
Hospital and Medical Environments
Home and Occupational Environments
ADVERSE EFFECTS
In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system:
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.
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