SPINAL CORD STIMULATOR INJURY LAWSUITS

Fighting for Patients Injured by Defective Spinal Cord Stimulators

Spinal cord stimulators have been linked to tens of thousands of injuries, including electric shocks, burns, nerve damage, paralysis, and patient deaths. 

Levy Konigsberg is investigating spinal cord stimulator injury claims against Abbott, Boston Scientific, Medtronic, and Nevro for patients nationwide.

Spinal cord stimulators (SCS) are surgically implanted devices that send electrical currents through wires placed along the spine to block pain signals before they reach the brain. Roughly 50,000 to 60,000 of the devices are implanted each year in the United States, where they have been heavily marketed as a safe alternative to opioids for patients with chronic pain of the trunk and limbs. But federal injury data tells a different story. Spinal cord stimulators account for the third-highest number of medical device injury reports to the FDA and patients have reported being shocked and burned, suffering nerve damage, losing bowel and bladder control, and being left with permanent paralysis. Most spinal cord stimulators allegedly reached the market with little new clinical testing, and manufacturers have introduced hundreds of modified devices through an abbreviated supplement process without new clinical trials.

If you or a loved one was harmed by a spinal cord stimulator, contact us today.

What We Know About Spinal Cord Stimulator Injuries

• In September 2020, the FDA sent a letter to healthcare providers after receiving 107,728 medical device reports related to implanted spinal cord stimulators over a four-year period — including 497 reports associated with patient deaths, 77,937 patient injuries, and 29,294 device malfunctions.

The letter aimed to remind physicians to conduct a trial stimulation period before permanently implanting the devices — a warning that followed a June 2020 Public Citizen report accusing the agency of dangerously lax oversight of spinal cord stimulators and calling for the FDA to reassess whether approved devices should be removed from the market.

The most frequently reported patient problem was the devices’ failure to achieve or maintain adequate pain control. Other common problems included pain, unexpected therapeutic effects, infection, and discomfort.

The 497 death reports represented 428 unique patient deaths involving devices implanted between 2005 and 2020. In roughly 30% of those deaths with available timelines, the death occurred within 30 days of implantation.

• In November 2018, a joint investigation found that more than 80,000 spinal cord stimulator injury reports had been filed with the FDA since 2008 — the third-highest total among all types of medical devices the agency oversees.

Patients reported being shocked or burned and suffering spinal-cord nerve damage ranging from muscle weakness to paraplegia.

The investigation found the FDA allowed some stimulators to reach the market without new clinical studies, approving them largely on results from studies of earlier devices. St. Jude’s application for its first stimulator allegedly contained no original patient data, and Boston Scientific’s application for its Precision stimulator allegedly rested largely on older data plus a study of 26 patients tracked for as little as two weeks.

The investigation also found the ten largest device makers paid nearly $600 million to doctors or their hospitals in a single year. The year before, Medtronic paid $2.8 million to settle Justice Department claims that it harmed patients and defrauded federal health programs by providing physicians financial inducements that turned them into salesmen for costly procedures. 

Spinal Cord Stimulator FDA Recalls and Warnings

Federal regulators have repeatedly recalled spinal cord stimulator devices and components — including Class I recalls, the FDA’s most serious category for defects that can cause serious injury or death.

If your spinal cord stimulator was recalled — or if you were injured by a device that was never recalled — you may have a legal claim. Contact Levy Konigsberg today.

Boston Scientific Infinion CX Leads — Class I Recall (2026)

• In June 2026, Boston Scientific recalled its Infinion CX leads — the thin wires that deliver electrical current to the spine. However, the recall only pulled unused leads off the shelves. It did not include leads that were already implanted in patients’ bodies.

The wires reportedly can weaken and fracture at the point where they are anchored in the body, causing the device to stop delivering adequate pain relief and forcing patients to undergo additional surgery to remove and replace the lead.

As of May 2026, Boston Scientific had reported 1,081 serious injuries linked to this defect.

Abbott Proclaim and Infinity Pulse Generators — Class I Recall (2023)

• In July 2023, Abbott recalled more than 155,000 implanted pulse generators — the battery units that power the stimulator — across its Proclaim XR, Proclaim Plus, Proclaim DRG, and Infinity lines.

When patients put their device into MRI mode — which switches off pain therapy so they can safely undergo an MRI scan — some found they could not turn their therapy back on. Patients left stuck in MRI mode lost their pain relief entirely, and for many, the only fix was another surgery to remove the device and implant a new one.

Abbott reported 186 incidents and 73 injuries.

Abbott Eterna Stimulators — Communication Failure (2025)

• In October 2025, Abbott warned physicians that its Eterna spinal cord stimulators may lose the ability to communicate with the patient’s controller due to a manufacturing problem in the devices’ Bluetooth components — leaving patients unable to adjust or control their own stimulation.

Medtronic Stimulators, Programmers, and Leads — Repeated Recalls (2018–2026)

• Medtronic’s spinal cord stimulation products have been the subject of a long series of FDA recalls, covering nearly every part of the system: the implanted Intellis and Vanta stimulators themselves, the software applications clinicians use to program patients’ stimulation settings, the lead wires placed along the spine, and the rechargers patients depend on to keep their devices powered.

Recalls have been issued repeatedly, including in 2023, 2024, 2025, and 2026.

Spinal Cord Stimulator Injury Lawsuits 

Patients across the country have filed lawsuits against all four major spinal cord stimulator manufacturers — Abbott, Boston Scientific, Medtronic, and Nevro — and federal courts have now consolidated some claims into multidistrict litigations (MDLs).

By July 2026, all four manufacturers faced lawsuits in state and federal courts, with plaintiffs alleging the companies made hundreds of modifications to device software, firmware, battery systems, and stimulation settings through the FDA’s supplement process without new clinical trials or full regulatory review.

Nevro Spinal Cord Stimulator Litigation (MDL No. 3195)

• In October 2026, the U.S. Judicial Panel on Multidistrict Litigation centralized 17 lawsuits against Nevro Corporation in the Northern District of California.

Plaintiffs allege the FDA granted premarket approval of Nevro’s spinal cord stimulator based not on Nevro-sponsored clinical trials but on published literature about similar systems made by other companies — and that Nevro then introduced nearly 250 new devices with significant modifications through successive supplements to avoid the clinical evaluation required for new applications.

Plaintiffs allege Nevro failed to disclose the material changes to patients, physicians, or regulators, and failed to comply with manufacturing, adverse-event reporting, labeling, and post-market surveillance obligations.

Nearly all plaintiffs further allege Nevro sales representatives engaged in the unauthorized practice of medicine — actively programming and reprogramming implanted devices, adjusting the positioning of implanted leads, and directing patients to adjust their settings — and that representatives were trained to make false and misleading statements to patients and healthcare providers.

• In May 2026, a federal judge in Maryland denied Nevro’s motion to dismiss a lawsuit by a man implanted with Nevro’s Senza II stimulator. 

The plaintiff alleged that while a Nevro representative attempted to reprogram his device over the phone, it delivered two extremely painful electrical jolts down his right leg — a sensation he described as feeling like his leg was being blown off — leaving him with severe pain and weakness that required a cane and wheelchair even after the device was surgically removed.

Abbott Laboratories Spinal Cord Stimulator Litigation (MDL No. 3194)

• In October 2026, the U.S. Judicial Panel on Multidistrict Litigation centralized 15 lawsuits against Abbott Laboratories in the Northern District of Illinois — where Abbott is headquartered and ten actions were already pending — with 11 additional related actions noted across ten districts.

Plaintiffs allege Abbott obtained premarket approval based on published literature about other companies’ systems, introduced numerous modified devices through supplements to avoid heightened scrutiny, concealed known risks, and deprived physicians and patients of the information needed to evaluate the devices’ true dangers.

Nearly all plaintiffs allege Abbott sales representatives engaged in the unauthorized practice of medicine by programming, reprogramming, and making therapeutic adjustments to patients’ devices — often numerous times, without a physician present.

• In April 2025, a Kentucky woman sued Medtronic and the FDA, alleging the stimulator implanted in her in 2015 — a device whose original premarket approval dated to 1984 — was materially altered by hundreds of supplement approvals that upgraded its software and capabilities without the rigorous scientific review Congress intended for Class III devices, and that she suffered complications traceable to those upgrades.

Boston Scientific Spinal Cord Stimulator Litigation (MDL No. 3181)

• In June 2026, the U.S. Judicial Panel on Multidistrict Litigation consolidated the federal lawsuits against Boston Scientific into MDL No. 3181 in the Central District of California, where Boston Scientific’s neuromodulation division is headquartered.

Patients allege they suffered shocking, burning, lead migration, nerve damage, and loss of pain relief from Boston Scientific’s spinal cord stimulators.

The lawsuits allege Boston Scientific got its devices approved based on studies of other companies’ products rather than clinical studies of its own, then introduced new devices with significant modifications while avoiding the safety review.

Patients also allege Boston Scientific sales representatives routinely entered operating rooms during implantation surgeries, advised on where leads were positioned, and participated in programming the devices during surgery.

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