Spinal Cord Stimulator Lawyers for Lead Failures, Shocks, and Explant Surgery

Doctors usually offer a spinal cord stimulator after other treatments for chronic back or leg pain have not worked. Some patients get real relief. Others report the opposite: shocks they cannot control, leads that break or drift out of place, a second or third surgery to fix or remove the hardware, and in some cases new nerve damage.

Those reports are now the subject of three separate federal multidistrict litigations (MDLs), one each for Boston Scientific, Abbott, and Nevro stimulators, plus individual lawsuits against Medtronic. Jeffrey Glassman Injury Lawyers is a personal injury firm reviewing spinal cord stimulator cases from every state. The review is free by our spinal cord stimulator attorneys. We are paid only if you recover.

A stimulator has three parts. Thin wires called leads are placed along the spine in the epidural space. A battery-powered pulse generator, about the size of a stopwatch, is implanted under the skin of the buttock or abdomen. A handheld remote or app adjusts the settings. The system sends electrical stimulation to the spinal cord to change how pain signals are processed. Different systems use different waveforms, so they do not all work the same way.

Stimulators are Class III medical devices, the FDA's highest-risk category, and they reach the market through premarket approval (PMA). Later changes to an approved device, from new hardware to software updates, are usually approved through PMA supplements. A supplement is a normal regulatory route. Many of the lawsuits allege that some changes were significant enough to deserve closer review than they got. That is an allegation, not a finding, and it ties directly into the legal fight described below.

Systems you may recognize:

• Boston Scientific: Precision, Spectra WaveWriter, WaveWriter Alpha, and Infinion leads
• Abbott: Proclaim and Eterna
• Nevro: Senza systems, which deliver Nevro's HFX therapy (Globus Medical acquired Nevro in 2025)
• Medtronic: Intellis, Vanta, and Inceptiv

A product appearing on this list does not mean every model has the same alleged defect. Each case starts with identifying exactly which generator and leads you have.

Complaints filed in these cases allege problems including:

• Leads that fracture or migrate, sometimes into the spinal canal
• Painful shocks or overstimulation, including during charging or MRI mode
• Battery and charging failures
• Pain that worsens after implant
• Nerve damage, spinal cord compression, and in some cases paralysis or loss of bowel and bladder control
• Infection, and hardware eroding through the skin
• Revision or explant surgery, sometimes more than once

These are allegations. Each one still has to be proven with medical evidence in an individual case.

On September 3, 2020, the FDA sent a letter to health care providers about stimulator risks. It reviewed 107,728 adverse event reports received over roughly four years, starting in July 2016. More than 30,000 reported inadequate pain relief. The agency also noted 428 reported deaths among stimulator patients from 2005 to 2020. Those are reports, not proof: the FDA said the reports do not establish that the devices caused the deaths, and many patients had other serious health conditions. The FDA recommended that doctors complete an adequate trial stimulation before permanent implant, consistent with the device labeling.

On September 3, 2026, the FDA posted a notice about Boston Scientific's removal of unused Infinion CX leads (models SC-2317-50 and SC-2317-70), which it identified as the most serious type of recall. This recall covers leads still on the shelf. It does not call for removing leads already implanted. According to the company's June 17, 2026 letter to customers, mechanical stress at the anchor site can cause high impedance readings, a sign of an electrical conduction problem, or lead fracture. Either can leave a patient without adequate stimulation and may require replacing the lead. Boston Scientific reported 1,081 serious injuries and no deaths as of May 27, 2026.

Early in 2026, plaintiffs asked the Judicial Panel on Multidistrict Litigation to combine cases against Boston Scientific and Abbott before one judge. The panel declined to group different manufacturers together, citing differences among the companies, devices, and alleged defects. It has since built the litigation one manufacturer at a time.

Boston Scientific: MDL 3181. Created June 5, 2026, in the U.S. District Court for the Central District of California before Judge Josephine L. Staton. The panel's October 1, 2026 report lists 41 pending cases. Plaintiffs' leadership was appointed in August 2026, and the court allows new cases to be filed directly in the MDL. Master complaints and motions to dismiss are being briefed into early 2027. No bellwether trials have been scheduled. Boston Scientific is headquartered in Marlborough, Massachusetts.

Abbott: MDL 3194. Created October 2, 2026, in the Northern District of Illinois before Judge Lindsay C. Jenkins. The transfer order covered 26 cases from 13 federal districts. Abbott opposed centralization.

Nevro: MDL 3195. Created the same day in the Northern District of California before Judge Haywood S. Gilliam, Jr. The order covered 23 cases from 10 districts. Nevro also opposed centralization.

The panel chose not to put all three before one judge. In its words, "Little efficiency will be gained by placing SCS device MDLs against multiple manufacturers before one judge."

Medtronic: no MDL. Medtronic cases are proceeding individually. On July 14, 2026, a federal judge in Minnesota ruled on four Medtronic stimulator suits. Some claims were dismissed as filed too late under the patients' home-state deadlines, most of the rest were dismissed as preempted, and claims the patients brought against the FDA were dismissed for lack of standing. One patient's manufacturing-defect claim was allowed to go forward.

There is no global settlement and no settlement program in any of these litigations as of October 2026.

Because stimulators went through premarket approval, manufacturers argue that federal law blocks most state-law injury claims. The U.S. Supreme Court accepted the core of that argument in Riegel v. Medtronic, Inc. (2008). A state-law claim cannot impose requirements that are "different from, or in addition to" what the FDA required for the device. In practice, that makes it very hard to argue that an approved device should have been designed differently, or should have carried a different warning than the FDA approved.

A second rule, from Buckman Co. v. Plaintiffs' Legal Committee (2001), blocks claims that exist only to enforce a company's duties to the FDA, such as a claim that the company misled the agency during approval.

Both rules were applied in Dunham v. Boston Scientific Corp., decided in the Western District of Michigan on February 24, 2026. The court dismissed every claim against Boston Scientific, including manufacturing defect, failure to warn, warranty, negligence, and fraud, with prejudice.

What survives is a narrow category called a "parallel" claim: a traditional state-law claim based on the manufacturer violating the FDA's own requirements for that device. The clearest example is a manufacturing defect, meaning the device implanted in a patient was not made the way the FDA approved. That is the claim that survived in the Minnesota Medtronic ruling. To hold up, a parallel claim generally has to identify the specific federal requirement that was violated, show how that particular device departed from it, and connect the departure to the injury. How much detail a complaint must include varies among federal circuits.

This is where Jeffrey Glassman Injury Lawyers puts its effort in a stimulator case: the device's approval and supplement history, its specifications, the failure that actually occurred, and the medical and engineering evidence connecting them. A device that did not relieve pain, without more, rarely supports a claim that survives preemption.

We are reviewing cases for people with an implanted spinal cord stimulator who went through one or more of the following:

• Revision or explant surgery after a lead fracture, lead migration, or device malfunction
• Shocks or burns from the device
• New or worsening nerve damage, weakness, or paralysis
• Loss of bowel or bladder control
• Serious infection connected to the hardware
• The death of a family member after implant complications

A complication alone does not establish a claim. What makes a case worth pursuing is a documented device problem, such as a fractured lead noted in an operative report or high impedance recorded during a programming check, tied by medical evidence to a serious injury, and filed in time. The evidence still has to show why the device failed, not only that it did.

Deadlines are set by state law, and they vary. Some states allow as little as one year for a personal injury claim. When the clock starts also varies: depending on the state, it may run from the injury, or from when you knew or should have known the injury and its possible connection to the device. In the Minnesota Medtronic ruling, the court counted from points such as a doctor's instruction to turn the device off or a sudden onset of new symptoms, not from when the patients later heard about litigation.

Three more points:

• Statutes of repose. Some states set an outer limit measured from the sale or delivery of the product. These can cut off a claim even when the discovery rule would otherwise extend the deadline.
• Different claims, different clocks. A wrongful death claim, a survival claim, and a spouse's claim can each run on their own deadline.
• An MDL does not extend the deadline. Filing into an MDL does not create one national deadline. Your state's rules still control.

Doctrines such as fraudulent concealment can pause a deadline in some states, but they are evaluated case by case. If your device has been turned off, revised, or removed, or a doctor has told you it failed, have your deadline checked now.

If explant or revision surgery is already planned, ask your surgeon whether the removed hardware can be preserved and released rather than discarded. Never delay medical care to protect evidence; that is your doctor's call. Also keep:

• Your patient ID card, remote, and charger
• Programming and interrogation reports, including impedance readings
• Operative reports for implant, revision, and explant
• Any letters or notices from the manufacturer

These records help show what failed and when. Whether a claim avoids preemption is a separate legal question, but it cannot be answered without them.

We identify your exact generator and leads, including model, serial, and lot numbers where available. We gather the implant, programming, and revision records, and review the device's regulatory history alongside your medical timeline with qualified medical and engineering consultants. We then work out which state's law and deadlines apply. If the facts support a claim, we file in the appropriate court. For most cases that will be the federal MDL for your device's manufacturer, though filing location depends on the parties and the claims. We advance the case costs, and you pay no attorney's fee unless we recover for you.

To start a free review, call Jeffrey Glassman Injury Lawyers at (617) 777-7777 or contact us online. We are based in Boston and review stimulator cases from every state.

No. Stimulator injury claims are individual lawsuits grouped into MDLs for pretrial work such as discovery and motions. Each person keeps their own case and is compensated, if at all, for their own injuries. Jeffrey Glassman Injury Lawyers files each client's case individually. Cases that do not resolve in the MDL can be sent back to the court where they were filed for trial.

It depends on the manufacturer. Boston Scientific cases go to MDL 3181 in the Central District of California, Abbott cases to MDL 3194 in the Northern District of Illinois, and Nevro cases to MDL 3195 in the Northern District of California. Medtronic cases have no MDL. Your implant card or operative report usually identifies the manufacturer, and Jeffrey Glassman Injury Lawyers can confirm it from your records.

Possibly, but intermittent problems are harder to prove than a documented failure. The key question is whether a doctor has recorded a specific device problem, such as high impedance, a fractured or migrated lead, or a charging failure, and what treatment followed. Jeffrey Glassman Injury Lawyers reviews those records with you before giving an opinion.

No. Removal is a medical decision for you and your doctor, never a legal one. If removal is already planned, ask whether the hardware can be preserved, because it can be important evidence. Jeffrey Glassman Injury Lawyers can send a preservation request to the hospital on your behalf.

Not by itself. The 2026 recall covers unused leads, not leads already implanted. If your Infinion CX lead has fractured, shown high impedance, or been replaced, Jeffrey Glassman Injury Lawyers will review whether that failure supports a claim.

No reliable average exists yet: the MDLs are new and there is no settlement program. Value in device cases generally depends on the number of surgeries, whether nerve injury is permanent, medical costs, lost income, effects on daily life, the strength of the defect and causation evidence, and how well the claim holds up against preemption. Jeffrey Glassman Injury Lawyers explains those factors as they apply to your records rather than quoting a number.

This page is attorney advertising and general information, not legal or medical advice. Litigation facts are current as of October 2026 and can change. Do not turn off, reprogram, or remove an implanted device without talking to your doctor. Reviewed by the attorneys of Jeffrey Glassman Injury Lawyers.