If your Medtronic spinal cord stimulator stopped working, failed to provide pain relief, or required emergency revision surgery, you may have legal options. Generally, you can pursue a claim for a spinal cord stimulator malfunction or failure under defective medical device law and, in some cases, medical malpractice.
The path forward depends on proving that the device itself was defective, or that your medical team made preventable errors during implantation or follow-up care, or both.
This article walks through how these devices work, why they fail, what FDA recall history shows about Medtronic systems, and what you need to know about filing a claim in New York after a stimulator malfunction or revision surgery.
Prior results do not guarantee a similar outcome.
What Spinal Cord Stimulators Are Supposed to Do
Spinal cord stimulators are implantable neuromodulation devices used to treat chronic pain when conservative treatments like physical therapy, medications, and injections haven’t worked. A typical system has three parts:
An implantable pulse generator, a battery-powered unit similar to a pacemaker, placed under the skin, usually in the lower back or abdomen
Leads or electrodes, positioned in the epidural space along the spinal cord to deliver electrical pulses
Extension cables and connectors, linking the generator to the leads, along with an external programmer or charging device the patient uses to adjust settings
The idea behind spinal cord stimulation is that controlled electrical pulses can interrupt pain signals traveling to the brain, providing relief for conditions like failed back surgery syndrome, complex regional pain syndrome, and neuropathic pain.
When it works, patients can experience significant pain reduction and improved quality of life. But these are complex electronic devices implanted in the body, and they can fail in ways that cause serious harm.
Why Medtronic Spinal Cord Stimulators Fail
Medical literature and FDA adverse event data identify several categories of complications and failure modes affecting spinal cord stimulators across manufacturers, including Medtronic.
Hardware problems are among the most common:
Lead migration, where the electrode moves away from its target position, causing loss of pain coverage or new pain.
Lead fracture or insulation failure, where the thin wires break or their coating deteriorates, often from repeated movement
Generator failure, from battery issues or electronics malfunction, leaving the patient without stimulation
Connector failures, loosening, or corrosion at the points where leads attach to extension cables or the generator, interrupting the electrical signal
Biological and surgical complications include infection at the generator pocket or in the epidural space, epidural hematoma or nerve injury during implantation or revision, and wound dehiscence, where the incision fails to heal and exposes hardware to infection risk.
Programming and software issues have grown more important as these systems become more sophisticated, including loss of efficacy despite adjustments, and software glitches that prevent effective programming or mode switching, which became a documented problem with certain Medtronic models.
Patient tolerance issues round out the picture, including new or worsened pain after implantation, or intolerance of the tingling sensations (paresthesias) that older stimulator models produce.
Revision surgery is common in this field. Published studies report revision rates roughly in the range of 15% to 40% over several years, for lead repositioning, hardware replacement, or complete removal.
What Does the FDA’s Record Show for Medtronic Devices?
FDA adverse event reports and recall history provide important context for whether Medtronic spinal cord stimulators have documented, recognized problems, not just isolated complaints.
Four recent examples:
March 2024 (posted April 2024): A Class II recall for the Intellis Implantable Neurostimulator with AdaptiveStim, Model 97715. The manufacturer-reported issue was that a device could not be reprogrammed; the cause was still under investigation by Medtronic at the time of the notice.
June 2023: A Class II recall for certain Vanta with AdaptiveStim Implantable Neurostimulators, Model 977006, affecting 3,791 devices, for a design vulnerability where a cardioversion procedure (used to restore normal heart rhythm) could damage the device’s electronics and render it unresponsive. As of the notice, Medtronic had received two complaints tied to this issue, both resulting in explant surgery.
October 2024: A separate Class II recall for other Vanta Model 977006 devices, for batteries that depleted faster than clinicians or patients expected, potentially requiring earlier-than-planned reprogramming or surgical replacement.
April 2025: A Class II recall for the Stimulation RC Clinician Programmer Application, Model A71400, used with Inceptiv and Intellis Pro neurostimulators. A software issue could permanently disable communication with the implanted device when a specific intraoperative programming sequence was used.
A Class II recall means the FDA determined that use of the device may cause temporary or reversible harm, or that the probability of serious harm is remote.
That’s a lower severity tier than a Class I recall, but it’s still a regulatory finding serious enough to require manufacturer notification and corrective action.
Can You Sue for a Defective Spinal Cord Stimulator?
Yes. These claims generally fall under New York’s product liability law, which recognizes several theories that allow injured patients to recover damages when a medical device causes harm:
Strict products liability. A manufacturer is liable when it sells a product in a defective condition that’s unreasonably dangerous to the user, the product reaches the consumer without substantial change, and the defect causes physical harm. You don’t have to prove the manufacturer was negligent, only that the product was defective and caused your injury.
Design defect. The stimulator’s design makes it unreasonably dangerous when used as intended, such as vulnerability to cardioversion damage, programming architecture that prevents mode switching, or connector designs prone to corrosion. New York applies a risk-utility test, meaning you generally need to show a feasible safer alternative design existed at the time of manufacture.
Manufacturing defect. A particular unit departs from the intended design because of component misassembly, faulty soldering, bad insulation, or another production error.
Failure to warn. The manufacturer didn’t adequately warn patients and doctors about known risks, such as irreversible failure after certain medical procedures, programming glitches causing sudden loss of therapy, or specific activities that could damage leads or connectors.
Negligent design, testing, or warning. These overlap with strict liability but are grounded in fault, arguing the manufacturer failed to exercise reasonable care in designing, testing, or updating warnings as new risk information emerged.
Breach of warranty. The product failed to conform to specific representations the manufacturer made about it, whether in labeling, sales materials, or statements to providers or patients.
These claims are generally directed at the manufacturer and any distributors involved in supplying the device, not your surgical team.
New York courts have generally held that hospitals and surgeons aren’t treated as product sellers for implanted devices, since their primary business is providing medical services, not selling products, so a product liability claim focuses on the manufacturer and supply chain.
Can You Sue for Medical Malpractice?
Separate from a device defect claim, you may have a medical malpractice case if your healthcare providers deviated from the accepted standard of care in implanting, managing, or revising your stimulator. Examples include:
Misplacing leads during implantation, causing nerve damage or spinal cord injury that wouldn’t have occurred with proper technique
Failing to follow sterile technique, resulting in a preventable infection
Ignoring signs of device failure or infection and delaying necessary revision surgery
Negligently programming the device in a way that causes injury
A New York malpractice claim generally requires proving that the provider owed you a duty of care, that they deviated from the accepted standard of care, that the deviation proximately caused your injury, and that you suffered damages.
The standard of care is established through expert testimony, typically from neurosurgeons, pain management specialists, or anesthesiologists familiar with these devices, not by statute.
How Long Do You Have to File a Claim in New York?
Product liability. Generally three years from the date of injury under CPLR 214(5). For an implanted device, New York courts have generally started this clock on the date the device actually malfunctioned and caused injury, not the date of implantation. If your stimulator was implanted in 2020 but didn’t malfunction until 2024, your three-year window generally runs from 2024.
Medical malpractice. Generally two years and six months from the act, omission, or end of continuous treatment for the same condition, under CPLR 214-a. There are narrow exceptions for foreign objects, minors, and certain diagnostic errors, but the standard 2.5-year rule applies to most stimulator malpractice cases.
Because these deadlines differ and can run from different trigger dates, it’s worth having both potential claims reviewed together rather than assuming one general deadline applies.
Even though the product liability window is longer, waiting isn’t free: evidence can disappear, memories fade, and building a strong case takes time.
What Evidence Matters in These Cases
Implant records. Device model, serial number, and lot number, which let experts determine exactly which device was implanted and whether it was subject to a recall or a pattern of similar failures.
Programming logs and interrogation reports, showing how the device was configured and when problems started.
Surgery notes from revision or explant procedures, which often contain the surgeon’s direct observations, such as a fractured lead, an unresponsive generator, or connector corrosion.
Manufacturer communications, including recall notices and field safety notifications sent to your doctor.
FDA recall postings and MAUDE data, which can show other patients experienced similar failures with the same device model.
Medical and financial records, documenting pain levels before and after failure, functional limitations, treatments, medical bills, and lost wages.
The failed device itself, or components removed during revision surgery, can often be physically examined by experts. Preserving this evidence is important, which is one reason to talk to a lawyer soon after a device failure.
Does Having Revision Surgery Help or Hurt Your Case?
Revision surgery doesn’t erase an underlying device defect, and it can actually strengthen a case in several ways. A doctor recommending revision is itself evidence that the device wasn’t functioning properly.
When a surgeon goes back in to fix or replace a stimulator, they can see and document exactly what went wrong, whether that’s a fractured lead, damaged electronics, or visible corrosion at the connectors.
That direct observation is often more persuasive than expert opinion based on records alone.
Revision surgery also creates its own damages: new pain, complications, and risk, plus the financial costs of surgery, anesthesia, hospital stay, and time off work.
If the revision goes well, you may still have a claim for the harm suffered between the original failure and the successful revision.
If the revision itself causes injury, such as nerve damage or infection, you may have both a product claim for the defect that necessitated surgery and a separate malpractice claim if the surgeon deviated from the standard of care during the revision itself.
Federal Preemption and Why It Matters
Many Medtronic spinal cord stimulators are Class III medical devices that received FDA premarket approval (PMA), which creates a legal complication called federal preemption.
Since 2008, the law has generally held that state law claims imposing device requirements different from, or in addition to, what the FDA approved through the PMA process can be preempted by federal law.
If a lawsuit would effectively require a device to meet a design or warning standard beyond what the FDA approved, a court may dismiss it as preempted.
However, “parallel claims,” alleging that the manufacturer violated federal requirements that already applied, can generally survive preemption.
These might include claims that the manufacturer failed to report adverse events to the FDA as required, that the device as manufactured deviated from its FDA-approved specifications, or that its labeling didn’t comply with FDA requirements.
When Should You Talk to a Lawyer?
Consider a consultation if any of the following apply:
Your stimulator stopped working unexpectedly, leaving you without stimulation and with returning pain
The device became unresponsive or couldn’t be reprogrammed, especially after an MRI or cardioversion procedure
You needed unplanned revision or explant surgery due to hardware failure or a documented device error
You developed a serious infection in the generator pocket or epidural space requiring surgery and IV antibiotics
You experienced new neurologic deficits after lead migration or device failure
Your device model appears in an FDA recall or safety alert, or you’ve found reports of similar failures with your model
Frequently Asked Questions
Does needing revision surgery automatically mean I have a case?
No. Spinal cord stimulators have a known revision rate even when properly designed and implanted, so revision alone isn’t proof of a defect or negligence. What matters is whether the device failed in an abnormal way, whether the manufacturer’s design, testing, or warnings fell short, or whether your medical team departed from the standard of care. Your surgery notes and device records are usually the starting point for answering that.
Can I sue if my device is a PMA-approved device like most Medtronic stimulators?
Possibly, but PMA approval can trigger federal preemption, which limits certain state law claims against the manufacturer. Claims alleging the manufacturer violated a federal requirement that already applied, such as failing to report adverse events or deviating from its FDA-approved manufacturing specifications, can often proceed despite preemption. This is a technical area where experienced counsel makes a real difference in how a claim is framed.
Can I sue my surgeon and Medtronic for the same device failure?
Sometimes, if both a device defect and negligent care contributed to your injury. They’re separate legal theories with different deadlines and different proof requirements, so it’s worth having both evaluated rather than assuming only one applies.
What if my stimulator worked fine for years before it failed?
That’s common, and it doesn’t bar a product liability claim. New York generally starts the three-year clock for product liability claims on implanted devices from the date the device actually malfunctioned and caused injury, not the date it was implanted.
How soon should I talk to an attorney after a device failure or revision surgery?
As soon as possible. Evidence like device logs, programming records, and the explanted hardware itself can be harder to obtain the longer you wait, and building these cases takes time even though the product liability deadline is longer than the malpractice deadline.
Summing It Up
A spinal cord stimulator failure or unplanned revision surgery can undo months or years of hard-won pain relief, and it’s worth understanding whether the device, the care you received, or both fell short.
FDA recall history and adverse event data show that specific Medtronic models have had documented, recognized problems, but every case still depends on your specific device, your medical records, and expert review.
Porter Law Group represents New Yorkers harmed by defective medical devices and medical negligence, working with experienced medical and engineering experts to evaluate each client’s case.
This article is for informational and educational purposes only. It is not a substitute for medical advice from a qualified healthcare provider or legal advice based on your specific circumstances.
If your Medtronic spinal cord stimulator failed or required unplanned revision surgery, call 833-PORTER9, email info@porterlawteam.com, or reach us through our contact page for a free, confidential consultation. Prior results do not guarantee a similar outcome.
