Abbott Spinal Cord Stimulator Lawsuit (2026): MDL 3194

By Ronald V. Miller, Jr. | Miller & Zois | Updated November 2, 2026

Abbott spinal cord stimulator lawsuits are being filed by patients who say devices intended to relieve their chronic pain instead caused electrical shocks, burning sensations, worsening pain, neurological injuries, and additional surgery. Some patients say their stimulators failed after repeated reprogramming attempts. Others allege that the leads moved, that the system stopped delivering treatment, or that Abbott representatives became more involved in their medical care than they should have, putting Abbott’s interests ahead of the patients’ well-being.

That paragraph is a nutshell of what this litigation is about. The number of filed cases is low right now, but our lawyers believe this litigation will eventually involve thousands of claims. We are getting a lot of calls in these cases, and lawyers we work with are also reporting that they are developing huge inventories of these cases.

On October 2, 2026, the federal judicial panel created MDL No. 3194 to coordinate related Abbott cases for pretrial proceedings in the Northern District of Illinois. The cases are assigned to U.S. District Judge Lindsay C. Jenkins.

This page focuses on Abbott, Proclaim, Eterna, and related St. Jude Medical spinal cord stimulation systems. In these lawsuits, Abbott is the largest piece of the larger spinal cord litigation puzzle. For a comparison of all four manufacturers and the broader litigation, see our spinal cord stimulator lawsuit guide.

Who May Have an Abbott Spinal Cord Stimulator Lawsuit?

Our lawyers are reviewing selected spinal cord stimulator claims. We are most interested in cases where medical records can reconstruct the injury and device history, including situations involving serious electrical shocks, burns, lead migration, or additional surgery.

Our firm’s existing screening criteria for spinal cord stimulator cases are:

• The stimulator was implanted within the last 10 years.
• The patient experienced injuries that appear to be connected to the device’s wiring or operation. We are particularly interested in cases involving painful electrical shocks, burns, or device migration.
• We are looking at infection cases, but only those involving a revision surgery or some other severe response.
• We generally are not accepting cases governed by a one-year statute of limitations, but some serious cases will warrant an exception. Paralysis would be a good example of something that would likely warrant an exception to that rule.
• We generally are not accepting cases with a filing deadline within the next six months unless, again, the injuries are extreme.

Those are our law firm’s current intake guidelines, not the legal criteria for spinal cord stimulator eligibility. Certainly, there are patients outside these guidelines who still have a legal claim and should get advice about the applicable deadline. Implant date, injury date, the state whose law applies, and the nature of the injury can all affect the analysis. We are just giving victims a heads-up on the types of claims our law firm is considering.

The first three questions we are going to ask you are (1) whether the device was removed or revised, (2) what the surgeon has told you, and (3) whether you received repeated programming adjustments before the problem was resolved. If you still have texts, emails, or patient portal messages involving an Abbott representative, we will ask to see them, and you should preserve them if you are considering bringing a compensation claim.

Abbott Spinal Cord Stimulator MDL No. 3194 Updates

The original push in this litigation was to have all of the spinal cord stimulator defendants in one massive piece of litigation. The MDL Panel that decides these things disagreed. So now we are going to have multiple federal MDLs. Boston Scientific cases are centralized in MDL No. 3181 in the Central District of California, and on the same day it created the Abbott MDL, the Panel created a separate Nevro MDL, No. 3195, in the Northern District of California.

On October 2, 2026, the Judicial Panel on Multidistrict Litigation transferred the Abbott spinal cord stimulator lawsuits for coordinated pretrial proceedings in Chicago, where Judge Lindsay Jenkins will handle issues shared across the lawsuits. The JPML transfer order identified 15 actions in its original schedule and discussed a larger group of related cases. More cases have followed, and many more cases will follow.

Once the court allows discovery involving Abbott to begin, where do we start? Abbott’s own FDA submissions, design changes, warnings, complaint handling, and interactions between its device representatives and treating physicians.

November 2, 2026: MDL Case Count

There are now 27 lawsuits pending in the Abbott spinal cord MDL..

October 13, 2026: The court issues its first case management order

Judge Jenkins entered Case Management Order No. 1. This is a standard order in an MDL that combines Abbott actions for pretrial management, temporarily stays discovery until the initial conference and further order, and tells the parties to preserve relevant evidence. Motions pending before transfer must be refiled in the new court.

The first scheduling conference is set for November 12, 2026. The judge plans to discuss which plaintiffs’ lawyers will lead the litigation and the possible filing of consolidated complaints. So there may be one central set of allegations that new cases can piggyback on, while each plaintiff keeps an individual damages claim.

The court has ordered evidence preservation before the parties have even finalized the discovery rules. In this litigation, the programming history and communications with company representatives could become just as important as the operative report. That is a concrete reason for injured patients to save their records now.

October 2, 2026: Federal Abbott lawsuits are centralized

In creating MDL No. 3194, the JPML identified common questions about whether Abbott followed federal requirements when it modified earlier approved devices and whether its warnings kept pace with the technology. It also noted allegations that company representatives performed programming or therapeutic adjustments without appropriate medical supervision. Abbott opposed centralization and disputes the underlying allegations.

Which Abbott Spinal Cord Stimulator Models Are Involved?

Patients often know that they received a spinal stimulator but cannot remember its model name. We expect that.

Abbott purchased St. Jude Medical, and several products may be described in older medical records by the St. Jude or Advanced Neuromodulation Systems names.

Products referenced in complaints or relevant FDA records include the Proclaim XR and Proclaim Plus spinal cord stimulation families and the Eterna system. A Proclaim DRG device stimulates the dorsal root ganglion rather than using conventional spinal cord stimulation. (Abbott’s Infinity system, sometimes listed alongside Proclaim in an FDA recall, is a deep brain stimulator and really should not be described as an Abbott spinal cord stimulator.)

What Problems Are Alleged in Abbott Stimulator Lawsuits?

Painful electrical shocks and burning sensations

Some plaintiffs say that a device implanted to relieve pain began delivering sudden, painful shocks or burning sensations. It is a scary, awful feeling when a patient cannot make the symptoms stop through normal programming or when the shocks continue after several office visits. The medical issue is what caused the symptoms. We contend that too often they were caused by a defect in the device or a problem with its leads. Abbott may argue that the symptoms were caused by the implantation procedure or the patient’s underlying medical condition.

Lead migration and revision surgery

Lead migration is when an electrode lead has moved away from where it was supposed to be. A patient can lose the benefit of stimulation or begin experiencing a different pattern of pain. An imaging study can often show where the leads ended up. If the leads must be surgically repositioned, the revision operation and the records explaining why it was necessary are important evidence.

We will not win one of these cases by just proving migration. Plaintiffs’ lawyers will need to look at the original placement, any warning signs, how the device was secured, and what the manufacturer told physicians about the risks.

Loss of therapy, connection failure, and repeated reprogramming

A patient may report that a trial stimulator produced meaningful relief, but the permanent implant never worked the same way. Others describe repeated attempts to adjust the device, followed by more pain, sudden therapy loss, or a recommendation for removal.

That history can tell us more than the diagnosis on the last visit. We want to know how many reprogramming sessions occurred, who performed them, what the settings were, and whether the patient was warned about the consequences of continued adjustments. Those details are often scattered among the treating physician’s records, manufacturer records, and communications with representatives.

Neurological injury, weakness, and loss of function

Some Abbott lawsuits describe weakness, numbness, serious nerve symptoms, bowel or bladder problems, or other loss of function after implantation. These are potentially devastating injuries, but they require careful medical proof. The patient may have had a significant underlying spinal condition before implantation. A good case has to separate what was already present from what changed after the device was implanted, activated, reprogrammed, revised, or removed.

Where possible, records of neurological examinations, imaging, emergency visits, and the timing of any new symptoms can help answer that question.

Abbott Spinal Cord Stimulator Recalls: Proclaim and Eterna

Several different FDA actions are relevant to patients researching Abbott spinal cord stimulator problems. They involve different devices and different failure mechanisms.

2023 Class I recall: Proclaim devices unable to exit MRI mode

The FDA classified a correction involving certain Proclaim and Infinity implantable pulse generators as a Class I recall. Abbott initiated the action on July 18, 2023. The FDA notice identifies 155,028 distributed devices across the listed product families, including some deep brain stimulators that are not SCS devices.

The problem involved patients who could not exit MRI mode because the controller lost its ability to communicate with the implant. MRI mode disables therapy. In some circumstances, restoring therapy could require surgery to remove and replace the generator. The FDA reported 186 incidents and 73 injuries in its recall communication, with no reported deaths at that time.

A patient who received an electrical shock from migrated leads does not automatically have the same issue as a patient whose device became locked in MRI mode. We need the model, the events leading up to the malfunction, and the treatment records before connecting an individual injury to any recall.

2024 Class II recall: Proclaim battery replacement warning may come too late

In May 2024, Abbott initiated another correction involving certain Proclaim pulse generators. The FDA classified the action as a Class II recall for the Proclaim XR 5, and its records also identify the Proclaim XR 7. The concern was the time between the device’s elective replacement indicator, which is supposed to warn that the battery is approaching the end of its useful life, and the device actually reaching end of service. That interval could be shorter than the product labeling indicated.

Abbott sent an urgent medical device correction notice to affected customers in June 2024. The notice instructed physicians to discuss when to replace a generator after an elective replacement warning and how to reduce the risk of an interruption in therapy. This was a different problem from the 2023 MRI mode recall. A patient who unexpectedly lost stimulation should preserve the generator identification, battery warning history, and any records showing when the device stopped working.

2025 Class II recall: Eterna generator communication problems

A separate FDA Class II recall entry concerns certain Abbott Eterna SCS implantable pulse generators, model 32400. Abbott initiated a device correction in October 2025 after identifying a potential issue affecting communication with the clinician programmer or patient controller.

Abbott provided more detail in an October 2025 letter to physicians. The company reported 36 complaints involving the Bluetooth communication problem. Of those, 21 involved implanted devices that required another procedure to replace the generator; 15 involved devices that failed communication checks before implantation. Abbott described an issue with a Bluetooth Low Energy circuit component and said it had introduced additional manufacturing checks.

This differs from both the 2023 Proclaim MRI mode action and the 2024 Proclaim battery warning correction because it involves a different product and different circumstances. The notice also describes steps for unused affected devices and guidance for patients whose devices are already implanted. As always, you should not make medical decisions based on general statements lawyers like us make that could be out of context. Discuss any alert or suspected malfunction with your treating physician, who can guide you on how to approach it.

Why Abbott Sales Representatives Matter in These Cases

Most mass tort claims our lawyers handle focus only on the product, not what the sales representatives may or may not have said. But this litigation seems to be heading down the path of a close look at what these sales reps were doing and saying. In fact, the JPML transfer order specifically talks about plaintiffs’ allegations that Abbott representatives did more than just explain how a product worked. According to the complaints, some representatives got in the weeds of patient care and programmed, reprogrammed, or made therapeutic adjustments to implanted systems, sometimes repeatedly and without a doctor.

No one is arguing that device representatives cannot legitimately assist physicians with technical information and programming. The question here is whether it went beyond that. Was a representative carrying out the doctor’s instructions? Was the physician supervising? Did the representative make independent treatment recommendations or minimize serious symptoms? Did someone assure the patient that another reprogramming session would solve a problem that later required surgery?

Plaintiffs will want pretrial discovery about representative training, written policies, call notes, programming records, instructions provided to physicians, and the company’s response when patients reported continuing problems. We are also going to want to know what was actually said to doctors and patients.

FDA Approval, Federal Preemption, and the Abbott Lawsuits

Abbott spinal cord stimulation systems are Class III medical devices regulated through the FDA’s premarket approval process. The law also permits manufacturers to seek approval for changes through PMA supplements. The existence of a supplement does not, by itself, prove that the company avoided required testing or violated federal law.

Plaintiffs allege that successive changes to device electronics, software, wireless programming, batteries, and other features were significant enough that the original approval and subsequent warnings no longer adequately addressed the product’s risks. Abbott disputes that theory. The October 2 transfer order identifies that regulatory history as a central subject for coordinated discovery, not as a judicial finding that Abbott violated the law.

There is another obstacle plaintiffs’ lawyers know well: federal preemption. Under 21 U.S.C. Section 360k and the Supreme Court’s decision in Riegel v. Medtronic, many state-law claims that would impose requirements different from or additional to federal device requirements may be barred. Some claims alleging violations of federal requirements that also support an independent state-law duty can proceed, depending on the facts and the governing law.

This is why it is not enough to say that a stimulator malfunctioned. A lawyer needs to connect the medical injury to a legally viable theory about how the product was manufactured, labeled, marketed, or used.

A dismissed Abbott case shows how quickly filing deadlines can end a claim

On July 30, 2025, a federal judge in Illinois dismissed a Proclaim case because the plaintiff filed too late under the Tennessee statute of limitations. The court applied Tennessee law based on where the device was implanted and the injury occurred. The plaintiff argued that she had learned of the potential legal claim only recently, but the judge concluded that the relevant notice of injury came earlier. The complaint was dismissed with prejudice. You can read the court’s order in Krantz v. Abbott Laboratories.

The court did not decide whether Abbott’s device was defective. It resolved that case on timing grounds. The lesson for prospective plaintiffs is practical: the creation of a new MDL does not restart filing deadlines. The law of the patient’s home state or the state of injury may control even though the MDL is in Illinois.

What Evidence Should Patients Save?

Let’s start out by saying the obvious: save everything. You also want to put together, at some point early in the process, a timeline for your lawyers. Write down when the trial stimulator was used, when the permanent Abbott device was implanted, what symptoms changed, every reprogramming attempt, and the dates of revision or explant surgery.

• Implant card and product stickers: These identify the manufacturer, generator, leads, model numbers, and often serial or lot numbers.
• Operative reports: Save the original surgery report and any revision or removal reports, including the surgeon’s documented reason for operating again.
• Programming and device interrogation records: Request records of programming adjustments, error messages, loss of communication, and testing of the implanted system.
• Communications with Abbott representatives: This is a major issue in this litigation. It is okay if you never had any contact with the sales rep. But if you did, preserve emails, texts, appointment notes, and any written instructions about setting changes.
• Medical proof of the injury: Preserve imaging, neurological examinations, emergency department visits, pain management records, physical therapy records, and any documents explaining new functional limitations.
• Financial losses: Keep records of additional medical bills, missed work, care needs, and travel costs attributable to the alleged malfunction or corrective surgery.

If a device is surgically removed, talk with your lawyer and treating physician about whether and how the explanted components can be preserved and identified. Any arrangements should be made through the appropriate medical and legal channels. Do not attempt to remove equipment, adjust implanted settings, or interrupt prescribed care for purposes of a lawsuit. You obviously want to put your health first.

Abbott Spinal Cord Stimulator Lawsuit Settlement Amounts

Our lawyers are generally unafraid to estimate potential settlement amounts in mass tort cases. We have already made those estimates for the broader spinal cord stimulator litigation, and we think they provide a reasonable starting point for Abbott lawsuits, too.

But you want to take settlement payout predictions from us or anyone with a few buckets of salt when they come this early in the litigation. But when lawyers decide to get involved in a specific litigation, they have to do a cost-benefit analysis to decide whether to move forward. So we think it is good to lay out what is admittedly a best-case scenario if this litigation is successful. We tell you this because we want to be very clear about the limitations of settlement estimates generally, but particularly at this stage of the litigation when we do not even know yet whether the litigation will be successful.

Our Abbott Spinal Cord Stimulator Settlement Projections

These are our lawyers’ preliminary settlement estimates based on injury severity, the need for additional surgery, and the extent of permanent harm. We are using the same ranges we developed for the broader spinal cord stimulator litigation because the Abbott litigation has not yet produced enough discovery to justify different projections.

These estimates assume plaintiffs can establish liability and causation. They are our projections, not actual Abbott settlement averages or promises of what any individual case will recover.

For additional discussion of how we reached these numbers, see our spinal cord stimulator settlement projections.

Abbott Spinal Cord Stimulator Lawsuit Questions

Is there an Abbott spinal cord stimulator class action lawsuit?

A federal multidistrict litigation, MDL No. 3194, covers related Abbott product liability cases. It coordinates pretrial work but does not convert individual injury lawsuits into one class action.

This is a much better outcome for most victims with serious injuries than a class action lawsuit. In an MDL, one judge oversees pretrial discovery that affects all these cases. But you still keep your own individual damages claim instead of being lumped into a pile with everyone else.

What is the next Abbott spinal cord stimulator court date?

Judge Lindsay C. Jenkins scheduled the initial MDL status conference for November 12, 2026, at 10 a.m. Central Time in Chicago. The court will address case organization and future procedures. This litigation is just getting started.

Was the Abbott Proclaim spinal cord stimulator recalled?

Yes. The FDA classified a 2023 correction involving certain Proclaim generators as a Class I recall because some devices could become unable to exit MRI mode. A separate 2024 Class II recall addressed a shorter-than-labeled interval between the elective battery replacement warning and the end of service for certain Proclaim generators. The 2023 notice also listed Infinity deep brain stimulators, which are not SCS devices.

Was the Abbott Eterna stimulator recalled?

The FDA lists a separate Class II recall initiated in October 2025 involving certain Eterna SCS implantable generators, model 32400, because of a potential communication issue with programming devices. Patients should discuss their device and any concerns with the treating clinician.

Can I sue Abbott if I never had the stimulator removed?

Possibly. Explantation or revision surgery often provides important documentation, but it is not the only way to establish a device injury. The exact problem, proof of malfunction, lasting harm, and available legal claims matter. Our firm’s current intake criteria focus on selected serious injuries.

When will Abbott spinal cord stimulator settlement checks go out?

The reality is that we are likely a long way from that. This litigation is just beginning, and quick settlements in an MDL happen, but they are rare. The MDL was created in October 2026 and is still just organizing its pretrial proceedings.

How do I know whether my spinal cord stimulator is Abbott, St. Jude Medical, or another brand?

Start with the implant identification card and the surgeon’s operative report. The medical record may identify the generator and leads separately. The exact model, serial number, implant date, and any subsequent replacements are more useful than the general brand name alone.

Talk to Our Lawyers About an Abbott Spinal Cord Stimulator Claim

If an Abbott spinal cord stimulator caused painful shocks, burns, lead migration, a serious neurological problem, or another complication requiring surgery, the important first step is to establish the medical timeline and identify the device. Our attorneys are reviewing selected cases involving spinal cord stimulators and can discuss what would be needed to evaluate your claim.

Call 800-553-8082 or contact Miller & Zois online for a free case review.

For continuing developments involving all manufacturers, see our national spinal cord stimulator lawsuit updates.