Spinal cord stimulator lawsuit

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Content Reviewed by:

Paul Harding

Date Last Updated: September 10, 2026

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Reported Spinal Cord Stimulator Injuries and Deaths

Patients receive spinal cord stimulators in hopes of pain relief, but government data and lawsuits allege that some instead experienced burns, shocks, organ dysfunction, permanent injuries, or death. Between 2016 and 2020, the U.S. Food and Drug Administration (FDA) received more than 107,000 complaints about these devices.

If you received a device from any of the companies below and experienced harmful side effects, you may be eligible to file a spinal cord stimulator claim:

Abbott

Boston Scientific

Medtronic

Nevro

Spinal cord stimulator lawsuits include the following allegations, among others:

Inadequate Testing: Lawsuits allege insufficient testing and underreporting of risks, leaving patients unaware of potential side effects.

Lack of Clinical Trials: Lawsuits allege that manufacturers made hundreds of changes to the originally approved devices, changes that should have required new clinical trials, yet they did not conduct them.

Failure to Warn: Lawsuits allege that certain companies knew or should have known of spinal cord stimulator risks but failed to warn patients and medical providers.

No or Reduced Effectiveness: Lawsuits and medical journal articles indicate that some patients receive no meaningful relief or experience diminishing pain relief over time, raising questions about the devices’ long-term value relative to their risks.

Device Malfunction: Spinal cord stimulator lawsuits allege that patients experience the following:

Battery defects, including short battery life or failure
Sudden worsening of pain
Loss of therapeutic effectiveness
Power failures
Shocking or burning sensations
Stimulator wire defects, including migration or breakage

Infection & Pain: Patients may develop severe infections or increased pain, requiring device removal or replacement.

Interested in learning more about your legal rights? Call us today at 1-800-529-1010 to speak with our legal team. Harding Mazzotti represents patients in spinal cord device lawsuits on a contingency basis, so you owe nothing unless our lawyers recover compensation for you.

What Is a Spinal Cord Stimulator?

Spinal cord stimulators are implanted medical devices that deliver low-level electrical signals to the spinal cord with the goal of reducing chronic pain.

A spinal cord stimulator typically includes electrode wires, called leads; an implanted device; and a small, pacemaker-like battery pack called a generator. The leads are placed in the epidural space, and the device delivers electrical impulses intended to reduce pain.

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You can call us at 1-800-LAW1010 or fill out a form. Even if you’re unsure if you have a case, our team is here to help you discuss your legal options at no charge.

How Do Spinal Cord Stimulators Work?

Spinal cord stimulators operate based on the “gate control theory” of pain: electrical pulses are intended to interrupt pain signals before they reach the brain. Although the theory may sound promising, lawsuits allege that many patients experience little to no lasting relief. Some report a brief “honeymoon phase” before effectiveness declines, while others say the device causes new problems, including shocks, burns, or worsening pain.

Effectiveness can vary widely depending on lead placement, nerve anatomy, and device programming. These factors may contribute to failure rates that exceed manufacturers’ advertised rates.

Spinal Cord Stimulator Manufacturers

Abbott

Abbott (formerly St. Jude) sells spinal cord stimulation systems for chronic pain. Recent lawsuits allege that Abbott failed to warn consumers about potential device risks.

People harmed by an Abbott or St. Jude spinal cord stimulator may be eligible to file a lawsuit. Because statutes of limitations restrict how long patients have to bring defective medical device claims, it is important to act quickly.

Abbott spinal cord stimulator models

Eterna™ SCS System
Proclaim™ Plus SCS System
Proclaim™ XR SCS System
Proclaim™ DRG System
Penta™ leads
Eon Mini™ implantable pulse generator

Boston Scientific

Boston Scientific develops spinal cord stimulation systems and related products for chronic pain treatment.

Patients have reported adverse health effects linked to Boston Scientific SCS devices, leading to Boston Scientific spinal cord stimulator lawsuits.

Boston Scientific spinal cord stimulator models

Precision Montage™ MRI SCS System
Precision™ SCS System
Spectra WaveWriter™ SCS System
WaveWriter Alpha™ SCS System

Medtronic

Medtronic manufactures medical devices, including spinal cord stimulators. Recent lawsuits allege that its devices were prone to lead migration, reduced effectiveness, and device fracture.

Patients who experienced complications may be eligible to file a Medtronic spinal cord stimulator lawsuit.

Medtronic spinal cord stimulator models

Inceptiv™ spinal cord stimulator (SCS)
Intellis™ Pro spinal cord stimulation system
Vanta™ neurostimulation system
Restore™ SCS System
Resume 2 neurostimulation surgical leads

Nevro (Globus Medical)

Nevro is a California-based medical device company primarily focused on products for patients with chronic pain. In April 2025, Globus Medical completed its acquisition of Nevro Corp. Recent allegations claim that Nevro’s spinal cord stimulation devices may be prone to failures, including lead migration, fracture, and battery malfunctions.

Patients who suffered harm after implantation have pursued claims against the company, including Nevro spinal cord stimulator lawsuits.

Nevro spinal cord stimulator models

Senza® spinal cord stimulation (SCS) System
Senza II® spinal cord stimulation (SCS) System
Senza Omnia™ spinal cord stimulation (SCS) System
HFX™ spinal cord stimulation (SCS) platform
HFX iQ™ spinal cord stimulation (SCS) system

Who Typically Receives a Spinal Cord Stimulator?

A study published in Neurospine, which reviewed data from more than 34,000 patients, identified common demographic characteristics among spinal cord stimulator recipients:

Age: Adults ages 65 to 84 were the most likely to receive a spinal cord stimulator.
Gender: Women made up nearly 60% of spinal cord stimulator procedures.
Overall use: Spinal cord stimulator use has continued to rise since the opioid epidemic.

Northwestern Medicine reports that the following conditions commonly lead to spinal cord stimulator procedures:

Failed Back Surgery Syndrome (FBSS): The leading indication for spinal cord stimulators, accounting for an estimated 40% to 50% of cases.
Complex Regional Pain Syndrome (CRPS): Women are disproportionately affected by CRPS, making up nearly 75% of patients with the condition who receive stimulators.
Diabetic Peripheral Neuropathy: A growing segment of spinal cord stimulator patients, especially when medication does not provide adequate relief.

What Problems Are Linked to Spinal Cord Stimulator Devices?

The central concern is that lawsuits allege these devices have failed to deliver the promised pain relief and, for thousands of patients, have caused serious harm.

The FDA approved the first spinal cord stimulator in 1981. Since then, the therapy has grown to account for about 70 percent of all neuromodulation treatments. An estimated 40,000 devices are implanted annually, roughly half in the United States. The cost of implantation ranges from $30,000 to $80,000.

Spinal cord stimulation is often promoted as a “last resort” for patients who have exhausted other chronic pain treatments. Many recipients are older, medically vulnerable, and have endured years of pain and multiple unsuccessful surgeries.

Many patients trusted that an FDA-approved device would be safe.

However, a 2025 study in the Journal of Pain Research suggests a different real-world outcome. The review examined more than 13,000 spinal cord stimulator patients across 25 studies and found that nearly 1 in 10 had the device removed, with explantation rates as high as 38% in some studies. Lack of meaningful pain relief was the most common reason for removal.

Symptoms of Spinal Cord Stimulator Injuries

Legal filings allege that spinal cord stimulators may provide only short-term pain relief, if any, and can cause serious injuries related to lead migration, fracture, overheating, excessive or prolonged shocks, and other complications. People with implanted spinal cord stimulators may wish to speak with an attorney to determine whether they may have a claim.

Potential spinal cord stimulator side effects and symptoms include:

Tingling or numbness
Fever
Excessive or prolonged shocks
Returning or worsening pain
Skin erosion
Signs of infection
Sudden loss of paresthesia
Nerve damage
Scar tissue formation
Paralysis

According to an article in Current Pain and Headache Reports, spinal cord stimulator complication rates may range from 30% to 40%. Hardware-related problems, such as lead migration and battery failure, were among the most common causes of injury.

Spinal Cord Stimulator Recalls and Global Safety Actions

Regulators in the U.S. and abroad have responded to growing safety concerns involving spinal cord stimulators through recalls, warnings, and, in some cases, market withdrawals.

The Food and Drug Administration has overseen several safety actions related to spinal cord stimulation systems. Abbott’s Proclaim and Infinity implantable pulse generators were subject to a Class I recall, the FDA’s most serious category, after patients were locked in MRI mode and lost therapy. The recall covered more than 155,000 Proclaim and Infinity devices distributed from 2015 to 2023. The FDA reported at least 186 incidents and 73 injuries linked to the defect, which could leave some patients unable to exit MRI mode without surgery.

In Australia, regulators took stronger action after more than 2,000 adverse event reports involving shocks, internal burns, infections, paralysis, device failure, and loss of efficacy. The Therapeutic Goods Administration canceled 12 models from the Australian Register of Therapeutic Goods and placed strict new conditions on more than 50 others.

Australian health data underscored the concern: about 41% of patients required reintervention or device removal within three years, compared with roughly 2.7% for common procedures such as hip replacement. Independent experts have questioned whether spinal cord stimulators provide better pain relief than placebo, given the high rates of complications and explantations.

About Spinal Cord Stimulator Lawsuits

Attorneys may pursue spinal cord stimulator claims based on:

Express and Implied Warranty Breaches: Sales representatives may have made specific promises about device performance and durability during the trial period or implantation process. If a device fails to meet those promises, it may support a breach of warranty claim.

Manufacturing Defects: Devices are approved to operate within specific temperature and electrical limits. If a device overheats or functions outside those limits, it may fail to meet its own design standards.

Failure to Report Adverse Events: Federal regulations require manufacturers to report adverse events to the FDA within 5 to 30 days. Failure to report known issues may create additional liability.

Negligence: Manufacturers are alleged to have inadequately trained sales representatives who often interact directly with patients about the devices, sometimes without physician supervision, including when changing device programming.

Fraud: Lawsuits allege that manufacturer representatives made false statements directly to patients to encourage implantation and secure payment approval from Medicare or private insurers.

Fraudulent Concealment: Manufacturers are alleged to have withheld important information from patients and physicians about failure rates, the likelihood of removal surgery, and known complications.

Using multiple legal theories can strengthen a claim and make it harder for manufacturers to rely solely on FDA approval as a defense.

Spinal Cord Stimulator Lawyers: Free Case Evaluation

If you or a family member experienced harmful side effects following a spinal cord stimulator procedure, you may be eligible to file a lawsuit against the manufacturer. Harding Mazzotti has experience in pharmaceutical and medical device cases and understands the regulatory and legal issues involved.

Our spinal cord injury lawyers work on a contingency basis, meaning we do not get paid unless you receive compensation. Contact our law firm today for a free, confidential case evaluation.

Why Choose Harding Mazzotti?

Harding Mazzotti is a personal injury law firm with decades of experience holding medical device manufacturers accountable.

When you hire Harding Mazzotti, you work with a firm with the resources, scientific expertise, and courtroom experience to take on major medical device manufacturers. We handle spinal cord stimulator cases on contingency, so you pay nothing unless we recover for you.

Call us today at 1-800-529-1010 or complete our contact form for a free case evaluation.

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