Every day, people from across the nation receive spinal cord stimulators with the promise of pain relief. But according to government data and lawsuits, thousands of patients have had little to no benefit from these devices while experiencing burns, shocks, organ dysfunction, permanent injuries, and even death. The U.S. Food and Drug Administration (FDA) received over 107,000 complaints from patients who received these devices between 2016 and 2020 alone.
If you received a device from any of the following companies and experienced little to no benefit and/or harmful side effects, you may be eligible to join the spinal cord stimulator lawsuit:
- Abbott (formerly St. Jude Medical)
- Boston Scientific (formerly Advanced Bionics or Nalu)
- Medtronic
- Nevro
Spinal cord stimulator lawsuits make the following allegations (among others):
Inadequate Testing: Lawsuits suggest lax testing and underreporting of risks, with patients unaware of potential side effects.
Lack of Clinical Trials: Lawsuits suggest that the manufacturers made hundreds of modifications to the originally approved devices, which should have required new clinical trials, but failed to conduct such new trials.
Failure to Warn: Lawsuits allege certain companies knew or should have known about the spinal cord stimulator risks but failed to warn patients and the medical community.
No or Decreased Effectiveness: Lawsuits and medical journal articles show that some patients experience no real relief or waning pain relief over time, thus calling into question the long-term value versus risks.
Device Malfunction: Spinal cord stimulator lawsuits say patients may experience the following:
- Battery defects (short life, failure)
- Causing sudden worsening of pain
- Loss of therapeutic efficacy
- Power failures
- Shocking or burning sensations
- Stimulator wire defects (migration, breakage)
Infection & Pain: Severe infections or increased pain requiring removal or replacement.
Surgical Complications: Infections (sepsis), nerve damage, hematomas, and device migration leading to severe pain or paralysis.
Interested in learning more about your legal rights? Call us today at (310) 207-3233 to speak with our legal team. Wisner Baum represents people in spinal cord device lawsuits on contingency, which means if our lawyers do not win compensation on your behalf, you owe nothing.
Spinal Cord Stimulator Lawsuit Update
The spinal cord stimulator litigation is rapidly evolving. Below are the most recent developments in these cases:
January 13, 2026: To start 2026, we wanted to provide you with a clear understanding of what the spinal cord stimulator lawsuits are about. These cases center on allegations that certain manufacturers failed to adequately warn about the risks of serious harm, including lead migration, device malfunction, infection, nerve damage, and, in some cases, the need for revision surgeries or explantation. Some plaintiffs allege the devices did not provide the pain relief that was represented.
Wisner Baum represents plaintiffs in SCS lawsuits. We believe this litigation will continue to grow this year. If you have any questions about these cases - or if you would like to speak with a spinal cord injury attorney about your claim - contact us today for a free and confidential case review. We pursue these cases on contingency, which simply means if we don't win compensation, you owe us nothing.
December 11, 2025: People may be wondering whether these spinal cord stimulator injury cases are going to be consolidated into a multidistrict litigation (MDL). As of today, there is no MDL for this litigation. As more cases are filed, however, the chance of an MDL being formed goes up.
October 17, 2025: Plaintiff Ollie Wilson filed a federal lawsuit against Boston Scientific Corporation in the U.S. District Court for the Central District of California, alleging the company's WaveWriter Alpha spinal cord stimulator caused serious harm. The Boston Scientific lawsuit alleges the spinal cord stimulator device malfunctioned immediately after the procedure, subjecting Wilson to severe electrical shocks and intense pain.
According to the complaint, Boston Scientific representatives allegedly met with Wilson without her doctor and told her that no other patients had experienced these problems. But the company's own internal adverse event records and FDA safety reports directly contradict these statements, the lawsuit says.
Spinal cord stimulator lawsuits say Boston Scientific exploited the FDA's premarket approval (PMA) supplement pathway to avoid rigorous safety reviews, thus enabling the company to sell devices with numerous modifications compared to the originally approved version. The spinal cord device lawsuit further alleges Boston Scientific knew its devices frequently migrated and delivered dangerous electrical surges but deliberately concealed these risks from patients and physicians.
September 16, 2025: Spinal cord attorneys for the plaintiff in Dena Lawler v. Boston Scientific Corporation et al filed a Notice of Voluntary Dismissal today. The dismissal was “without prejudice.” This could mean that a settlement has been reached, attorneys are filing in a new jurisdiction, or it simply could be a strategic pause in the case. Whatever the reason, the plaintiff still has the right to refile the spinal cord stimulator lawsuit against Boston Scientific.
May 1, 2025: Spinal cord injury lawyers filed a lawsuit in the U.S. District Court for the Central District of California against Boston Scientific over catastrophic failures involving her Spectra WaveWriter spinal cord stimulator. The complaint details how plaintiff Dena Lawler, who received the medical device in 2020 to treat chronic back pain, suffered immediate complications, including severe lead migration that required invasive revision surgery three months after she received the device.
More alarmingly, the device allegedly caused Lawler to develop cardiac arrhythmia and chest pain shortly after implantation. The lawsuit accuses Boston Scientific of bypassing critical safety regulations, accusing the company of using the FDA's premarket approval (PMA) supplement pathway to sidestep design modifications without rigorous safety testing. By avoiding a full PMA review for these major changes, the lawsuit says Boston Scientific allegedly compromised the device's safety and efficacy, directly leading to patient harm.
The latest spinal cord stimulator injury lawsuit seeks damages to hold the manufacturer accountable for prioritizing profit over patient safety.
What is a Spinal Cord Stimulator?
Spinal cord stimulators are implanted medical devices that send electricity at low levels directly into the spinal cord to supposedly relieve chronic pain.
A spinal cord stimulator consists of leads (electrode wires), the actual device, and a small, pacemaker-like battery pack (generator). The leads are placed between the spinal cord and vertebrae (epidural space). The device is programmed to send electrical impulses through the leads in a way that will supposedly relieve their pain.
The pulses of electricity target multiple muscle groups directly from the spine and can alter how the brain senses pain.
How Do Spinal Cord Stimulators Work?
Spinal cord stimulators are based on the “gate control theory” of pain. By delivering electrical pulses to specific nerves, the device attempts to “close the gate” on pain signals traveling to the brain.
While the theory sounds promising, the reality for many patients is different. According to lawsuits, some people experience a “honeymoon phase” in which the device works well for a few months, only for its effectiveness to fade significantly over time. For others, the device never provides the promised relief, or, worse, creates new problems such as unexpected shocks, burns, or worsening pain.
Effectiveness varies wildly based on lead placement, nerve anatomy, and device programming. These variables can lead to failure rates much higher than the manufacturers advertise.
Some Common Spinal Cord Stimulator Types
Boston Scientific (formerly Advanced Bionics or Nuro)
- WaveWriter Alpha
- Spectra WaveWriter
- Precision Montage
- Precision
Medtronic
- Intellis Pro
- Inceptiv
- Vanta
- Restore
- Resume 2
Abbott (formerly St. Jude)
- Proclaim XR
- Proclaim Plus
- Infinity
- Penta
- Eon Mini
Nevro (Globus Medical)
Who Gets a Spinal Cord Stimulator?
According to a study published in Neurospine, which looked at a patient pool of over 34,000 individuals, these are the key demographics for people who receive spinal cord stimulator devices:
- Age: People aged 65–84 were the most likely to receive a spinal cord stimulator.
- Gender: Women accounted for nearly 60% of all spinal cord stimulator procedures.
- Overall: Since the opioid epidemic, use of spinal cord stimulators has continued to grow.
Northwestern Medicine reports following conditions often lead to spinal cord stimulator procedures:
- Failed Back Surgery Syndrome (FBSS): This is the leading indication for spinal cord stimulators, accounting for an estimated 40-50% of cases. It affects 10-40% of patients after lumbar back surgery who experience persistent or recurrent pain
- Complex Regional Pain Syndrome (CRPS): Women are disproportionately affected by this condition, making up nearly 75% of the CRPS patient population receiving stimulators.
- Diabetic Peripheral Neuropathy: Over 37 million Americans have diabetes. Roughly 23% experience neuropathy. This is a growing segment of the spinal cord stimulator patient population, especially when medication fails to provide support.
What Are the Problems with Spinal Cord Stimulator Devices?
The biggest problem with these devices is that lawsuits allege they have not delivered what they promised, and for many thousands, they have caused serious harm.
The FDA approved the first spinal cord stimulator in 1981. Since then, the therapy has grown to account for roughly 70 percent of all neuromodulation treatments. An estimated 40,000 devices are implanted each year, with roughly half of that total in the United States. The cost of implantation ranges from $30,000 to $80,000.
Spinal cord stimulation is often marketed as something of a “last resort” for patients who have exhausted other options for chronic pain management. The typical patient is older and vulnerable, often enduring years of pain and multiple failed surgeries.
They trusted that a device approved by the FDA would be safe.
But according to a 2025 study published in the Journal of Pain Research, real-world data paints a different picture. The review analyzed over 13,000 spinal cord stimulator patients across 25 different studies and found that nearly 1 in 10 had their devices removed, with explantation rates reaching as high as 38% in some studies. The most common reason for removal was lack of meaningful pain relief.
Infection, device migration (moving out of place), and skin erosion are frequently reported adverse events. For many, the device that was supposed to end their pain has only created more pain.
The Evidence: What Independent Science Shows
Manufacturers market spinal cord stimulators as a proven treatment for chronic pain. But independent research shows these devices may not actually work better than a placebo for many patients.
No Better Than Placebo
A rigorous randomized clinical trial published in JAMA (October 2022) compared burst spinal cord stimulation against placebo stimulation in patients with chronic pain after back surgery. Burst spinal cord stimulation is a newer technology marketed as superior compared to older spinal cord stimulation treatments.
According to researchers, patients receiving actual burst stimulation experienced no better improvement in pain or disability than those receiving placebo. The mean disability score improved by 10.6 points with real stimulation versus 9.3 points with placebo, which is a difference so small it was statistically insignificant. Per the study authors: “This trial underlines the powerful placebo effect of invasive neuromodulation therapies.”
Effectiveness Disappears Over Time
A longitudinal study published in the European Journal of Pain (2022) followed 176 patients over seven months. While patients reported significant pain relief shortly after implantation, that benefit gradually evaporated. By the follow-up, patients with permanent implants had outcomes statistically indistinguishable from patients whose trial failed and received no implant at all. The researchers concluded: “SCS may not be effective for the majority of chronic pain patients.”
High Rates of Device Removal
An analysis of adverse events reported to Australia's Therapeutic Goods Administration found that devices are being removed at a rate of 4 in every 10 implanted. Of 520 adverse events between 2012 and 2019, nearly 80% were classified as “severe” and 13% were classified as “life-threatening.”
As a comparator, hip replacement is a major surgical procedure that requires additional surgery in only 2.7% of cases within three years. Spinal cord stimulators require reintervention in 41% of cases within the same timeframe.
How This Affects Spinal Stimulator Lawsuits
If these devices provide no better pain relief than a placebo and require removal in a significant number of cases, then the risks of surgery, infection, electrocution, and permanent disability become impossible to justify.
Patients are not simply dealing with device failure. They are dealing with the realization that they underwent an invasive, irreversible surgery for a treatment that independent research suggests does not work.
Spinal Cord Stimulator Recall Alerts and Global Safety Actions
Regulators in the U.S. and around the world have acted on growing safety concerns about spinal cord stimulators, including recalls, safety warnings, and, in some cases, outright market removal.
The Food and Drug Administration has overseen multiple safety actions involving spinal cord stimulation systems. Abbott’s Proclaim and Infinity implantable pulse generators were the subject of a Class I recall, the FDA’s most serious recall category, after patients became stuck in MRI mode and lost their therapy.
The recall covered more than 155,000 devices, including Proclaim XR 5 (3660), Proclaim XR 7 (3662), Proclaim Plus 5 (3670), Proclaim Plus 7 (3672), Proclaim DRG (3664), Infinity 5 (6660), and Infinity 7 (6662), distributed between 2015 and 2023. When the Patient Controller app lost its Bluetooth connection to the implant while in MRI mode, which can happen after an iOS or app update, some patients were unable to exit MRI mode at all, leaving surgery as the only option to restore stimulation. The FDA reported at least 186 incidents and 73 injuries tied to this defect.
In Australia, regulators took even more dramatic steps. After receiving more than 2,000 adverse event reports of shocks, internal burns, infections, paralysis, device failure, and loss of efficacy, the Therapeutic Goods Administration (TGA) conducted a post‑market review of spinal cord stimulator devices. That review led the TGA to cancel 12 spinal cord stimulator models from the Australian Register of Therapeutic Goods and impose strict new conditions on more than 50 additional models. Once cancelled, those devices can no longer be supplied or sold in Australia.
Australian health data highlighted why regulators acted: Roughly 41% of patients required reintervention or device removal within three years, compared with about 2.7% for common procedures like hip replacement. Independent experts questioned whether spinal cord stimulators provide any better pain relief than placebo, given such high complication and explant rates.
Legal Theories in Spinal Cord Stimulator Lawsuits – How Attorneys Aim to Hold Manufacturers Accountable
The spinal cord stimulator litigation is complex because manufacturers may be held liable under multiple legal theories. Attorneys may pursue claims based on:
Express and Implied Warranty Breaches: Manufacturers' sales representatives may have made specific promises about device performance and durability during the trial period and implantation process. When devices fail to meet these promises, it could constitute breach of warranty.
Manufacturing Defects: Devices are approved to heat to specific temperatures and operate within certain electrical parameters. If devices overheat or malfunction beyond these specifications, they may violate their own design standards.
Failure to Report Adverse Events: Federal regulations require manufacturers to report adverse events to the FDA within 5-30 days. If manufacturers fail to report known problems, this may create additional liability.
Negligence: Manufacturers are alleged to have been negligent in their training of their sales representatives who often, without doctor supervision, speak to and interact directly with patients concerning their devices, including changing the device’s programming.
Fraud: Manufacturers’ representatives are alleged to have made fraudulent statements directly to patients in order to get the patients to agree to implantation as well as to obtain approval for payment by Medicare and/or private insurance for the devices.
Fraudulent Concealment: Manufacturers are alleged to have withheld critical information about device failure rates, the likelihood of requiring removal surgery, and known complications from patients and doctors.
Using a multi-pronged approach strengthens your case and makes it harder for manufacturers to hide behind FDA approval of these devices.
Spinal Cord Stimulator Lawyers – Free Case Evaluation
If you or someone in your family experienced harmful side effects after a spinal cord stimulator procedure, you may qualify for a lawsuit against the manufacturer. Wisner Baum has extensive experience in mass tort litigation, particularly in pharmaceutical and medical device cases. Our team understands the complexity of these lawsuits, the regulatory issues involved, and how to hold large corporations accountable.
Our spinal cord injury lawyers work on a contingency basis, which means we don't get paid unless you receive compensation. Contact our law firm today for a free and confidential case evaluation.
