Lawsuit Information Center
A spinal cord stimulator is an implantable medical device used to manage chronic pain, most often involving the back or spine. These systems are marketed as a way to reduce pain by interrupting nerve signals before they reach the brain. But for a growing number of patients, the device fails to help. It introduces new and sometimes permanent problems, including electrical shocks, burning pain, infections, lead migration, hardware failure, and repeat surgeries to reposition or remove equipment that was supposed to improve quality of life.
This page explains spinal cord stimulator lawsuits and why they are being filed nationwide. It focuses on what patients are alleging, how these devices have failed in real-world use, and why many of these cases go beyond ordinary medical malpractice claims. The most serious lawsuits do not center on a single surgical mistake. They examine how modern spinal cord stimulators were designed, tested, and approved, and whether patients were ever adequately warned about the risks that now recur repeatedly in medical records and FDA reports.
Many victims want to know what spinal cord stimulator settlement amounts will look like and how we think compensation will be calculated, assuming an ultimate settlement. Settlement amounts and payouts in these cases will depend on several factors, which we dig into more fully below.
We also talk about what these cases are really about, who the defendants are, the regulatory history behind these devices, and the types of injuries being reported. This page was last updated on October 23, 2026.
Our lawyers are handling these claims nationwide. Get a free no-obligation consultation or call us today at 800-553-8082.
Last updated October 23, 2026
Which Spinal Cord Stimulator Manufacturers Have MDLs?
There are now three separate federal spinal cord stimulator MDLs. They are organized by manufacturer, not combined into one proceeding covering all devices.
| Manufacturer | MDL and court |
|---|---|
| Boston Scientific | MDL 3181, Central District of California, Judge Josephine Staton |
| Abbott | MDL 3194, Northern District of Illinois, Judge Lindsay Jenkins |
| Nevro (now owned by Globus Medical) | MDL 3195, Northern District of California, Judge Haywood Gilliam |
| Medtronic | No separate manufacturer MDL; cases are proceeding individually, including in Minnesota state court |
The JPML orders provide the official transfer history. An MDL coordinates pretrial proceedings; it is not a class action or an announced settlement.
Do You Have a Spinal Cord Stimulator Lawsuit?
Our firm is currently reviewing selected spinal cord stimulator claims. Our screening criteria are narrower than the universe of claims that may be legally possible, because we are focusing on cases with the clearest injury and timing evidence.
- The spinal cord stimulator was implanted within the last 10 years.
- The patient experienced injuries that may be associated with the device wiring, including painful electrical shocks or burns, or experienced device migration.
- We consider infection a qualifying injury only in cases involving revision surgery.
- As an intake matter, we generally are not accepting cases governed by a one-year statute of limitations unless the patient experienced paralysis.
- We generally are not accepting cases with a filing deadline within the next six months unless the patient experienced paralysis.
Please tell us if the device has already been removed or if explant surgery is scheduled. We are also very interested in any conversations with device sales representatives before or after implantation. Save texts, emails, portal messages, or other communications if you still have them.
These are our firm’s current case-screening criteria.
Spinal Cord Stimulator Lawsuit Updates
The JPML has now created separate federal proceedings for Boston Scientific, Abbott, and Nevro. Here are the latest developments, followed by the earlier filings and rulings.
October 6, 2026
JPML Creates Abbott and Nevro Spinal Cord Stimulator MDLs
As we expected, the U.S. Judicial Panel on Multidistrict Litigation wasted little time in approving separate MDLs for Abbott and Nevro spinal cord stimulator lawsuits. The Panel assigned the Abbott litigation to Judge Lindsay Jenkins in the Northern District of Illinois and the Nevro litigation to Judge Haywood Gilliam in the Northern District of California.
The Abbott proceeding is MDL No. 3194, and the Nevro proceeding is MDL No. 3195. Each judge will now oversee coordinated discovery and other pretrial proceedings for the federal lawsuits involving that manufacturer.
What surprises lawyers is the number of serious injury cases out there. The number of plaintiffs in these MDLs will start to multiply very quickly.
September 4, 2026
FDA Announces Class I Recall of Boston Scientific Spinal Cord Stimulator Leads
On September 3, the FDA announced a Class I recall involving certain Boston Scientific Infinion CX spinal cord stimulator leads. According to the FDA, Boston Scientific had reported 1,081 serious injuries and no deaths associated with the identified issue as of May 27, 2026.
The problem involves mechanical stress near the point where the lead is anchored. That stress can produce abnormal electrical resistance or lead fractures, potentially leaving patients with inadequate stimulation or requiring additional surgery to replace the lead.
Boston Scientific initiated the recall on June 17, 2026. The FDA posted it in its recall database on August 5 and issued its public communication on September 3. Class I is the FDA’s most serious recall category.
One important qualification: The removal action concerns unused Infinion CX leads. The FDA expressly states that it does not affect devices already implanted in patients. It is not an instruction for patients to have implanted leads surgically removed.
This recall matters for the Boston Scientific litigation. Lead fracture and loss of stimulation are serious device problems. But plaintiffs will still need to establish whether their specific leads were affected and whether a defect caused their injuries. If you have a Boston Scientific stimulator, the implant card and operative report are good places to start identifying the exact lead model.
What Will Spinal Stimulator Settlement Amounts Be?
When people ask about spinal stimulator settlement amounts, they are usually not asking out of curiosity. They are trying to understand whether the harm they suffered is being taken seriously and whether the legal system recognizes the scope of what went wrong. The truth is that spinal cord stimulator lawsuits are not really about chasing a number. They are intended to compensate for a cascade of losses that often follow implantation when these devices fail.
For many patients, the first injury is not the worst one. What follows can be months or years of repeat surgeries, hospitalizations, imaging studies, and failed attempts to fix a device that was supposed to reduce pain, not multiply it. Each revision surgery carries its own risks, costs, and recovery time. For some, the device never works as promised again. For others, it must be removed entirely, leaving them with permanent damage and no pain relief at all.
A less visible cost also shows up in almost every serious case: loss of trust in the medical system. Patients often feel dismissed when they report shocks, burning sensations, or worsening pain. They are told the symptoms are rare, expected, or unrelated, even as their quality of life steadily declines. That erosion of trust, combined with physical suffering and financial strain, is a core driver of these lawsuits.
Only after those realities are understood does it make sense to talk about settlement compensation and payouts. Higher spinal stimulator settlement amounts tend to be associated with cases involving clear, documented harm rather than temporary discomfort. The strongest cases often include multiple revision surgeries, complete explantation of the device, or injuries that permanently alter neurological function.
Illustrative Settlement Payout Scenarios
There is no average settlement for spinal cord stimulator lawsuits at this early stage of the litigation. The estimates below reflect our lawyers’ experience and judgment about how injury severity may affect potential value if liability and causation are established. They are not reported settlement averages, promises, or predictions of what any particular claimant will receive. The ranges overlap because surgery counts alone do not determine case value.
| Scenario | Our Illustrative Estimate |
|---|---|
| One revision surgery
Documented shocks or worsening pain, one corrective procedure, limited permanency. |
$90,000 to $250,000 |
| Explantation required
Removal surgery with ongoing pain, scarring, or functional limitations. |
$150,000 to $550,000 |
| Multiple surgeries or migration
Two or more revisions with documented migration, lead failure, or repeated loss of therapy. |
$250,000 to $500,000 |
| Permanent neurological injury
Objective nerve damage, weakness, gait changes, paralysis, or another lasting neurological deficit. |
$500,000 to $800,000 |
| Bowel, bladder, or autonomic injury
Permanent bowel or bladder loss, autonomic complications, and substantial loss of independence. |
$800,000 to $1,500,000 |
Have a spinal cord stimulator claim? If your device shocked or burned you, migrated, or required revision or removal surgery, call 800-553-8082 or contact our lawyers online. We are currently reviewing new cases.
Spinal Cord Stimulators
Spinal cord stimulation devices are Class III implantable neuromodulation systems intended to deliver controlled electrical impulses to the spinal cord to manage chronic, intractable pain. These systems generally include an implantable pulse generator, one or more electrical leads placed near the spinal cord, and an external controller that allows the patient to adjust stimulation levels.
The theory behind spinal cord stimulation is that targeted electrical impulses applied to the dorsal columns of the spinal cord can interfere with or alter the transmission of pain signals before they reach the brain. By modulating these signals, the devices are intended to provide relief for patients whose pain has not responded to conventional treatments.
There is no question that spinal cord stimulation systems have brought relief for some patients. But they also carry significant and well-documented risks that have been brushed under the rug. We are getting daily calls from victims reporting such things as device migration, lead fracture or displacement, battery malfunction, infection, neurological injury related to stimulation, worsening pain, and autonomic dysfunction.
Because of these substantial risks, the FDA classifies spinal cord stimulation systems as Class III medical devices. This designation requires rigorous Premarket Approval and supplemental review for design or functional modifications that could affect the device’s safety or effectiveness.
Spinal Cord Stimulator Lawsuits: Allegations of Defective Medical Devices
Across the United States, patients are filing lawsuits involving spinal cord stimulators, alleging these implantable pain-management devices were defectively designed and unreasonably dangerous. According to FDA adverse-event data, thousands of complaints have been reported involving spinal cord stimulators, including burns, infections, device migration, electrical malfunction, and the need for repeated corrective surgeries.
Major manufacturers, including Boston Scientific, Medtronic, Abbott, and Nevro, are accused of failing to adequately warn patients and physicians about known risks associated with these devices. Independent scientific studies have raised concerns about lead migration, hardware failure, and other complications associated with spinal cord stimulation.
Many patients report they were never fully informed of these dangers before implantation. After suffering burns, infections, worsening pain, paralysis, or undergoing revision surgeries or complete device removal, patients often face significant physical pain, emotional distress, and financial hardship. As a result, injured individuals and their families are pursuing spinal cord stimulator lawsuits to seek compensation and accountability.
What separates spinal cord stimulator lawsuits from ordinary medical malpractice cases is not just the severity of the injuries, but the regulatory and design history behind these devices. Many of the most serious claims now being filed do not focus solely on surgical error or isolated malfunction. Instead, they examine how modern spinal cord stimulators were approved, how dramatically they changed over time, and whether patients were ever protected by the safety testing they were led to believe occurred.
Reported Spinal Cord Stimulator Complications
Spinal cord stimulator injuries being alleged in lawsuits include:
- Lead migration requiring revision surgery
- Electrical malfunction causing shocks or burns
- Device overheating
- Hardware failure
- Infection
- Scar tissue complications
- Worsening neuropathic pain
- Paralysis or weakness
- Autonomic dysfunction
- Bowel or bladder loss
- Cardiac complications
- Death following postoperative complications
One reported case involved an elderly patient, whom we talk about in the earlier updates, who developed Ogilvie syndrome following implantation. The complication progressed to bowel rupture and multi-organ failure. While causation remains disputed, similar autonomic complications have been reported following neuromodulation procedures.
Another lawsuit alleges a WaveWriter Alpha stimulator migrated and delivered painful shocks, with company representatives allegedly adjusting the device without a physician present.
These fact patterns are not identical. But the themes are consistent: device movement, electrical malfunction, worsening symptoms, and inadequate warning.
How Do You Know Which Spinal Cord Stimulator You Have?
A surprising number of people contact us without knowing which company manufactured their spinal cord stimulator, much less a model number. So we do not expect you to know which one you had when you call us. But you will know when it was implanted, what happened afterward, and how much pain it has caused you.
Start with your implant identification card. It identifies the manufacturer, device model, and serial number. The operative report from the implantation surgery should also identify the implanted pulse generator and leads. Do not assume that the lead and generator are the same thing. A recall or product problem may involve one component rather than the entire system.
For example, Boston Scientific’s 2026 Infinion CX recall identifies lead kit models SC-2317-50 and SC-2317-70. The FDA’s removal action concerns unused leads. Simply having a Boston Scientific stimulator does not mean your implanted system was recalled or that removal surgery is recommended.
For a lawsuit, we want to identify the manufacturer, the exact model, when the device was implanted, any revision or explant surgery, and what the medical records say about the reason for the procedure. That information can make a significant difference in determining whether an injury involved a possible product defect, a surgical problem, or some other complication.
How FDA Approval Is Being Used as a Shield
One of the first things spinal cord stimulator manufacturers point to when patients are injured is FDA approval. This is their first line of defense: hide behind the FDA skirt. They want you to think that since the device was approved, it must be safe. But that framing omits the convoluted way spinal cord stimulators reached the market.
Spinal cord stimulators are classified as Class III medical devices, the highest risk category under federal law. So in theory, that classification means the device must undergo rigorous premarket approval, including clinical testing, before it can be sold.
That is the level of review patients reasonably expect for a Class III device, right? Make sure you have it right. Plaintiffs say manufacturers relied on supplemental approvals tied to much older devices, with changes that they argue did not receive adequate testing or warnings. But the law does permit supplemental approvals, and a supplement is not itself proof of wrongdoing.
Manufacturers are permitted to update devices through PMA supplements. Federal law permits PMA supplements for many types of changes, with the submission and supporting evidence depending on the nature of the modification. The problem arises when companies rely on this process to roll out sweeping design changes over many years without ever returning to the FDA for a full review.
In the spinal cord stimulator space, manufacturers have introduced major modifications to battery systems, lead designs, stimulation waveforms, wireless communication features, posture-adaptive algorithms, and multi-source current delivery. These are not cosmetic tweaks. They directly affect how electrical signals reach the spinal cord and how the device behaves inside the body.
Yet many of these changes were reviewed through supplemental submissions rather than new human trials. As a result, patients may be implanted with devices that are materially different from the versions originally approved, even though the FDA approval remains in place. From the patient’s perspective, the device appears fully vetted. Plaintiffs question whether the supporting safety evidence has always kept pace with the technology.
This regulatory issue matters in real-world terms. When a device malfunctions, migrates, overheats, or delivers unintended electrical shocks, manufacturers often argue that these outcomes fall within “known risks.” Plaintiffs want to know whether the warnings actually addressed the risks of the device that was implanted, including modifications made over the years.
Lawsuits now being filed across the country allege that manufacturers exploited this regulatory structure by stacking change upon change without conducting the testing needed to reveal long-term failure rates or rare but devastating complications. Plaintiffs also allege that warnings never reflected how these newer systems behaved once implanted in patients.
The result is a familiar argument in modern medical device litigation. FDA approval becomes both a regulatory milestone and a defense in civil lawsuits. But whether a particular lawsuit survives depends on the legal theory, the applicable federal requirements, and the evidence that the manufacturer violated those requirements. Courts have already rejected some of the broader regulatory theories advanced in spinal cord stimulator cases.
Our criticism remains that patients may bear the consequences when warnings and testing fail to keep up with changing technology. The manufacturers dispute those allegations. And proving them will require much more than showing that a device received a series of PMA supplements.
When Device Representatives Cross the Line Into Treatment
One of the more serious issues in the spinal cord stimulator litigation is that some lawsuits are not just about the device itself. Our lawyers rarely focus on the role manufacturer representatives play before and after implantation. Usually, the focus is just on the device itself. But this litigation is different because the sales reps really seemed to often be in the weeds of all of it. The sales reps are aggressive, and they often provide more than just technical support. We argue that in some cases, they help sell the implant by making assurances about long-term pain relief, clinical validation, and expected performance, then remaining heavily involved once problems begin.
We allege that in some cases, the manufacturer representatives took an active role in programming and reprogramming spinal cord stimulators after implantation, sometimes across multiple visits and with limited physician involvement. This can blur the line between technical support and treatment, especially when the representative becomes the patient’s primary contact after pain worsens, stimulation becomes erratic, or the device stops providing relief.
These allegations become even more troubling when paired with claims of lead migration, electrical shocks, or sudden loss of therapeutic benefit. One recurring theme in spinal stimulator lawsuits is that repeated device adjustments may be used as a temporary response to serious complications, even when the underlying issue may be hardware movement, system instability, or loss of efficacy that reprogramming cannot fix. This looks less like troubleshooting and more like a delay.
This strengthens several types of claims at once. It can support allegations involving negligent misrepresentation, breach of warranty, failure to warn, and broader negligence theories tied to post-implant conduct. It also gives juries a more concrete story. Instead of hearing only that a device failed, they hear that the manufacturer may have remained deeply involved while the patient’s condition worsened.
Abbott Recall History and Warning Failures
Another issue likely to matter in spinal cord stimulator litigation is whether patients and doctors were ever given a fair warning about how newer Abbott systems actually performed in the real world. The Abbott spinal cord stimulator lawsuits being filed do not just allege that these devices could fail in a general sense. We allege that important risks were understated, poorly communicated, or buried beneath broad assurances about safety and effectiveness.
Spinal cord stimulator complications are not limited to disappointing results. Painful electrical shocks, sudden loss of therapy, charging failures, communication problems between device components, lead migration, and worsening pain are all things patients have reported after implantation. In a device intended to treat chronic pain, those are not minor side effects. They go to the core question of whether the product was functioning safely at all.
Abbott also draws added scrutiny because of its recall history involving serious device problems. FDA Class I recalls are the agency’s most serious recall category, and complaints involving Proclaim-related systems have raised issues such as loss of therapy, device communication problems, and difficulties with MRI mode. The exact recall, model, and failure mechanism matter. We should not assume that every Abbott device or every patient complaint involves the same defect.
The broader allegation is that the warnings never kept pace with the technology. As spinal cord stimulator systems evolved through repeated supplemental changes to firmware, battery architecture, wireless programming, and stimulation features, we contend the risks evolved too. But, as our lawsuits argue, patients were still not clearly told that the device being implanted may have been materially different from the version originally approved years earlier.
That warning gap is a big deal in these cases. A manufacturer does not get much mileage out of saying a risk was technically known if the actual device changed over time and the real-world complications became more serious, more frequent, or simply different from what patients and doctors were led to expect. That is why the adequacy of warnings remains a central issue, even with the preemption fight hanging over these cases.
Repeated Reprogramming After Implantation Can Be a Warning Sign
One issue that does not get enough attention in spinal cord stimulator lawsuits is what happens after the permanent device is implanted and the patient starts complaining that something is wrong.
Many patients are told that the answer is simple: the device just needs to be reprogrammed. A representative adjusts the settings. The patient is told to give it more time. Then the pain comes back, the stimulation becomes uncomfortable, the device stops helping, or new symptoms develop. The cycle repeats.
That pattern matters. Reprogramming is not automatically improper. These devices often require adjustments after implantation. But repeated reprogramming can become a red flag when it is used as the default answer to every complaint, especially when the patient is reporting shocks, numbness, worsening pain, loss of balance, falls, bladder or bowel symptoms, or loss of therapeutic benefit.
At some point, the question should shift from “Can we adjust the settings again?” to “Is the device failing?”
This is especially important when company representatives become the main people managing the device after surgery. Patients may reasonably believe the representative is acting like part of the medical team. But manufacturer representatives are not neutral treating physicians. They work for the very company that sold the device. So when they reassure patients that complications can be fixed with another programming change, that can delay a real medical evaluation of whether the stimulator has migrated, malfunctioned, lost efficacy, or should be removed.
In spinal cord stimulator lawsuits, this reprogramming cycle can become key evidence. In some cases, it will show that the device was not performing as represented. It also may show that warnings were far from adequate. An extremely strong allegation would be if the manufacturer remained involved after implantation in a way that shaped the patient’s treatment decisions, not just the device’s technical settings.
So if repeated reprogramming does not restore meaningful relief, or if symptoms are getting worse, the problem may not be a settings problem. It may be a device problem.
Patients who experience these problems should document each reprogramming visit, who performed it, whether a physician was present, what symptoms were reported, what settings were changed, and whether the change actually helped. Those details can matter later if the device must be revised, removed, or becomes the basis for a legal claim.
New weakness, paralysis, or bowel or bladder changes also deserve prompt medical evaluation. Patients should not wait for a legal review to address potentially serious neurological symptoms.
Why Medtronic Is Now Being Sued in Minnesota State Court
Most spinal cord stimulator lawsuits are filed in federal court or in the state where the patient was implanted and injured. But plaintiffs across the country are choosing to file Medtronic stimulator lawsuits in Minnesota state court.
Why? Medtronic is headquartered in Minneapolis. Its regulatory strategy, labeling decisions, and post-market conduct were directed from that location. Filing in Minnesota puts the case before a local court that examines the conduct of a local company, and it may help plaintiffs avoid transfer into federal MDL proceedings. It also means discovery into Medtronic’s internal decision-making, including how it evaluated the risks of successive hardware modifications and what it chose to communicate to the medical community, takes place closer to where those decisions were made.
For patients implanted in other states, this approach requires a choice: file at home, where the injury occurred, or file in Minnesota, where Medtronic is based and where many of the company’s key decisions were allegedly made. Neither approach is universally right.
Why the Trial Stimulator and Permanent Implant May Not Match
This is one of the most frustrating patterns we see in spinal cord stimulator cases, and one that juries will understand immediately.
The patient does the trial. The trial works. The pain drops. For the first time in months or years, there is real relief. The doctor says the numbers look good. Everyone agrees it is time to move forward with the permanent implant.
Then the permanent device goes in. And somewhere down the line, weeks, months, sometimes longer, the relief fades. The pain returns. The hardware shifts. The system fails. The patient is left with a device inside their body that no longer functions as intended.
The essence of the problem is that a short trial cannot reliably predict long-term performance. A trial that goes well gives the patient a powerful reason to say yes to permanent implantation. Short duration. Different conditions. Sometimes a very different result months later. What the trial cannot tell the patient is whether the permanent implant will actually work six months or two years down the road.
Lawsuits now being filed challenge exactly this. We allege that the permanent device does not deliver the same results as the trial because the implanted system behaves differently over time, because the leads migrate or the hardware fails, or because the short-term trial window was never an honest preview of what permanent implantation would look like.
This matters because it reframes the entire case. The issue is not always that the patient got zero benefit. The issue is that the trial created false confidence in a treatment that the permanent device could not actually deliver. The patient did everything right. Followed the process and trusted the system. And ended up with the worst of both worlds. An invasive implant inside their body, and none of the long-term relief they were promised.
Our lawyers believe juries will understand why a successful temporary trial can influence a patient to accept permanent implantation. The legal question is whether the trial and marketing created reasonable expectations that the permanent system could not meet, and whether the patient received a fair warning about the risk of long-term failure, migration, and loss of efficacy.
Bringing a Spinal Cord Stimulator Lawsuit
If you or a loved one experienced complications after spinal cord stimulator implantation, including electrocution, burns, infections, neurological injury, or repeated surgeries, you may have legal options. Lawsuits seek compensation for medical costs, lost income, pain and suffering, and long-term disability, while holding manufacturers accountable for unsafe products and inadequate warnings.
Eligibility for a Spinal Cord Stimulator Lawsuit
Our firm is currently screening spinal cord stimulator cases based on a fairly specific set of facts. These are our intake criteria, not legal rules that determine whether every possible spinal cord stimulator claim has merit.
We are looking for clients who received a spinal cord stimulator implant within the last 10 years and later experienced injuries that may be associated with the wiring or operation of the device, particularly painful electrical shocks, burns, or device migration. We are considering infection as a qualifying injury only in cases involving revision surgery.
Timing also matters to our current intake. We generally are not accepting cases governed by a one-year statute of limitations unless the patient experienced paralysis. We also generally are not accepting cases where the filing deadline is within the next six months unless the patient experienced paralysis.
Explantation can be important evidence. If the device has already been removed, or a doctor has recommended removal and the surgery is scheduled, tell us that when you contact our office. Revision and explant records may help show device migration, wiring problems, malfunction, or another objective reason the system had to be corrected or removed.
We are also especially interested in what the patient remembers about conversations with device sales representatives before and after implantation. If a representative made promises about pain relief, safety, expected performance, reprogrammed the device after surgery, or responded to complaints about shocks, burns, migration, or loss of relief, those details may matter. Preserve texts, emails, portal messages, and other communications with company representatives whenever possible.
Spinal Cord Stimulator Lawsuit FAQs
Is there a spinal cord stimulator MDL?
Yes. The JPML created MDL No. 3181 for Boston Scientific spinal cord stimulator product liability cases on June 5, 2026. The cases are centralized in the Central District of California before Judge Josephine L. Staton. Abbott cases are separately centralized in MDL No. 3194 before Judge Lindsay Jenkins in the Northern District of Illinois, and Nevro cases in MDL No. 3195 before Judge Haywood Gilliam in the Northern District of California. Medtronic cases are not part of these three MDLs.
What are estimated spinal cord stimulator settlement amounts?
This litigation is just getting started. Separate federal MDLs now exist for Boston Scientific, Abbott, and Nevro. We estimate a range from the lower six figures for a documented revision case to more than $1 million for permanent neurological or autonomic injury. Those figures reflect our lawyers’ experience and judgment in mass torts like this and what we think of this litigation, but at this point it is guesswork until this litigation gets more legs.
Which spinal cord stimulator manufacturers are being sued?
Current lawsuits involve devices made by Boston Scientific, Abbott, Medtronic, and Nevro. Legal and regulatory issues differ by manufacturer and device family, so confirm the company name and exact model on the implant card or in medical records.
Does the Boston Scientific Infinion CX recall mean my stimulator must be removed?
No. The FDA’s September 2026 communication concerned removal of unused Infinion CX leads from distribution and use. It specifically states that the action does not affect devices that are already implanted. Patients experiencing problems should speak with their treating physician rather than assume that a recall automatically requires surgery.
Does explant surgery strengthen a spinal cord stimulator lawsuit?
It can. Explantation provides objective evidence that conservative measures and reprogramming did not solve the problem. Case value still depends on why the device was removed, whether a product defect caused the injury, how many procedures were performed, and the patient’s lasting symptoms.
Can I sue if the permanent stimulator never provided pain relief?
Lack of pain relief alone may not prove a product liability claim. The case becomes stronger when loss of efficacy is accompanied by lead migration, hardware failure, painful stimulation, misleading representations, repeated unsuccessful reprogramming, revision surgery, or explantation.
Does FDA approval prevent a spinal cord stimulator lawsuit?
FDA premarket approval creates a serious federal preemption defense, but it does not automatically bar every lawsuit. Some claims may proceed when they are based on a violation of federal requirements or a device that departed from its approved manufacturing specifications. The available theories depend heavily on the jurisdiction and the facts.
What records should I preserve?
Preserve the implant card, operative reports, imaging, revision and explant records, programming logs, communications with manufacturer representatives, photographs, symptom notes, medical bills, wage records, and the device itself if it is removed and can be retained through proper evidence procedures.
Example Lawsuit: Virginia Woman Sues FDA and Boston Scientific Over Defective Device
A Virginia woman has filed a spinal cord stimulator lawsuit against Boston Scientific and the U.S. Food and Drug Administration, alleging that a defective spinal cord stimulator caused severe and worsening injuries after implantation.
According to the complaint, the woman received a WaveWriter Alpha spinal cord stimulator to manage chronic pain, but instead, it made things worse, and she experienced electrical shocks, device migration, and escalating physical harm.
The lawsuit further alleges that the device moved from its intended position and delivered painful electrical impulses that were not only ineffective but also dangerous. Doctors sometimes call this migration, and it can cause real damage to the patient in many different contexts.
The patient also claims that company representatives adjusted and altered the device without her physician present, dismissing her concerns even as her condition deteriorated. If you are following this medical device, you would not be surprised, as the allegations mirror reports documented in FDA adverse-event data, in which other patients have described similar injuries linked to the same device system.
In addition to claims against the manufacturer, the lawsuit raises serious questions about regulatory oversight. The plaintiff alleges that Boston Scientific continued to market and sell a spinal cord stimulator that materially differed from the version originally approved by the FDA, without undergoing proper supplemental review or safety testing. The complaint asserts that these changes increased the risk of injury while depriving patients and physicians of critical information needed to make informed decisions.
The case highlights a growing concern in spinal cord stimulator litigation: that device manufacturers may prioritize speed to market and continued sales over patient safety, while regulators fail to intervene despite mounting evidence of harm. Although the case remains pending, it reflects broader allegations being raised nationwide by patients who say they were never adequately warned about the risks associated with these devices and who now face lasting pain, repeated procedures, and diminished quality of life.
Contact Us About Spinal Cord Stimulator Lawsuits
Our firm is seeking spinal cord stimulator lawsuits nationwide involving electrical shocks or burns, device migration, revision or explant surgery, and serious neurological injuries. If you believe your case may qualify, contact us today for a free case evaluation. Call us at 800-553-8082 or contact us online.
Page written by Ronald V. Miller Jr. This page is for patients and families trying to understand the connection between spinal cord stimulators and a variety of injuries, the federal MDLs, and potential civil compensation claims.