Abbott Spinal Cord Stimulator Lawsuit Overview

Abbott spinal cord stimulators are implantable pain management devices that deliver electrical pulses near the spinal cord in an attempt to interrupt pain signals before they reach the brain. The systems typically include a battery-powered implantable pulse generator, thin electrical leads placed near the spine and an external controller used to adjust the strength, location and pattern of stimulation.

The original line of Abbott spinal cord stimulation devices traces back to the Genesis system, which received FDA premarket approval in 2001. Lawsuits allege Abbott later used that decades-old approval as the foundation for newer Proclaim, Proclaim Plus, Proclaim XR, Proclaim DRG and Eterna devices that were substantially different from the original system.

Over the years, Abbott allegedly added new firmware, battery systems, wireless programming features, BurstDR stimulation and other waveform changes that altered how the devices worked inside the body.

Spinal cord stimulator lawsuits now claim these changes created new risks involving painful shocks, failed stimulation, numbness, weakness, worsening nerve pain, mobility problems and device removal surgery. Plaintiffs allege Abbott continued selling the devices without adequate clinical testing, updated warnings or full FDA review, leaving patients unaware that the implants could fail or cause severe injuries.

Abbott Spinal Cord Stimulator Models Named in Lawsuits

Abbott spinal cord stimulator lawsuits are being investigated for individuals who received any of the following devices:

• Eterna
• Proclaim Plus 5
• Proclaim Plus 7
• Proclaim XR
• Proclaim DRG
• Proclaim Elite
• Proclaim 5 Elite
• Prodigy
• Protégé
• Genesis
• Other Abbott, St. Jude Medical or Advanced Neuromodulation Systems spinal cord stimulation systems

Abbott Spinal Cord Stimulator Lawsuit Status

Abbott spinal cord stimulator lawsuits continue to be filed and investigated nationwide, with plaintiffs alleging that certain SCS systems were sold without adequate testing, warnings or regulatory review. These claims involve reports of device failures, lead problems, electrical shocks, loss of pain relief, worsening symptoms and the need for revision or removal surgery.

In February 2026, plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation to centralize spinal cord stimulator lawsuits involving Abbott and Boston Scientific before one judge for coordinated pretrial proceedings. The JPML heard oral arguments on May 28, 2026, and issued a transfer order on June 5, 2026.

The Panel created MDL No. 3181 for Boston Scientific spinal cord stimulator lawsuits, but did not centralize the Abbott cases at this stage. The order explained that the Abbott cases listed in the motion were all pending in the Northern District of Illinois, so they did not meet the requirement for a separate Abbott-only MDL involving cases in multiple federal districts.

Abbott spinal cord stimulator claims are still moving forward outside the Boston Scientific MDL. The JPML also made clear that its decision does not prevent Abbott cases from being centralized later if more lawsuits are filed in other federal districts and the litigation continues to expand.

Claims involving other spinal cord stimulator manufacturers are being pursued separately and are not part of any Abbott-only MDL at this stage. For more information about lawsuits involving other SCS device makers, see:

• Boston Scientific Spinal Cord Stimulator Lawsuits
• Medtronic Spinal Cord Stimulator Lawsuits
• Nevro Spinal Cord Stimulator Lawsuits

Abbott Spinal Cord Stimulator Feature Changes

Abbott’s spinal cord stimulator product line began with the Genesis Neurostimulation System, which was originally approved by the FDA more than 25 years ago. Lawsuits allege Abbott later used that decades-old approval as the foundation for newer devices that were substantially different from the original model, without adequate testing to determine whether those changes created new risks for patients.

Abbott Device Changes

• Firmware-controlled stimulation: Later Abbott systems allegedly relied on software and firmware to control therapy delivery. Plaintiffs claim these changes may have contributed to stimulation shutoff, unexpected therapy changes, painful shocks and inconsistent pain relief.
• BurstDR and high-frequency waveform programming: Abbott marketed newer stimulation modes that delivered electrical pulses in different patterns than earlier systems. Plaintiffs claim these waveform changes affected how stimulation interacted with the nervous system, without adequate clinical validation in the final devices implanted in patients.
• Bluetooth and wireless device control: Lawsuits allege newer Abbott systems used wireless programming features that created new risks involving communication failures, programming errors, therapy interruption or inability to control the device as intended.
• Rechargeable and non-rechargeable battery changes: Plaintiffs allege Abbott changed battery architecture and charging systems over time, creating risks involving device shutdown, shortened battery life, therapy loss, recharging failures and stimulation problems.
• MRI mode and controller issues: Some Abbott devices were subject to safety communications involving MRI mode, including concerns that a device could become stuck in MRI mode if the controller lost communication with the implantable pulse generator.
• Expanded device families and lead systems: Abbott’s product line grew from the original Genesis platform into multiple device families, including Proclaim, Proclaim DRG and Eterna. Plaintiffs claim these changes altered how stimulation reached the spinal cord or dorsal root ganglion, increasing the risk of lead migration, loss of coverage, nerve symptoms and revision surgery.

Lawsuits allege these changes were not routine updates. Plaintiffs claim Abbott substantially changed how its spinal cord stimulators worked inside the body, while continuing to rely on the original approval pathway rather than conducting adequate clinical testing on each new generation of devices.

Abbott Spinal Cord Stimulator Recalls

Several Abbott spinal cord stimulator recalls and safety communications have been issued in recent years impacting Proclaim, Proclaim DRG and Eterna devices over problems with MRI mode, battery replacement timing and device communication.

• November 7, 2025: The FDA posted a Class II recall for the Eterna SCS implantable pulse generator, Model 32400, involving potential loss of communication with the clinician programmer or patient controller. Affected patients could have difficulty adjusting stimulation settings or managing therapy until communication was restored.
• July 16, 2024: The FDA posted Class II recalls for Abbott spinal cord stimulator devices under PMA P010032, including Proclaim XR 5, Proclaim XR 7 and Proclaim 5 Elite implantable pulse generators. The recalls involved battery replacement timing, where devices could reach end of service sooner than the product labeling indicated, potentially resulting in loss of therapy or earlier battery replacement planning.
• June 2024: Abbott issued an urgent medical device correction for certain non-rechargeable Proclaim SCS, Proclaim DRG and Infinity devices involving the elective replacement indicator. The correction warned that the time between the elective replacement indicator and end of service could be shorter than stated in labeling, leaving patients with less time to schedule replacement before therapy ended.
• September 11, 2023: The FDA posted Class I recalls for Proclaim XR, Proclaim Plus and Proclaim DRG implantable pulse generators, involving MRI mode. If the patient controller could not communicate with the implanted pulse generator, the device could remain stuck in MRI mode, leaving stimulation therapy disabled.
• July 2023: Abbott issued an urgent medical device correction for Proclaim SCS, Proclaim DRG and Infinity systems involving MRI mode. Abbott warned that patients who could not exit MRI mode could lose stimulation therapy and, if troubleshooting failed, could require replacement of the implantable pulse generator to restore therapy.

Abbott Spinal Cord Stimulator Side Effects

Abbott spinal cord stimulator lawsuits describe complications that allegedly developed after patients received permanent Proclaim, Proclaim DRG, Eterna or related St. Jude Medical devices. Many of the claims involve patients who reported that the implant either failed to control their pain or created new symptoms that required repeated reprogramming, additional medical visits, revision surgery or removal of the device.

Abbott Spinal Cord Stimulator Problems

Abbott spinal cord stimulator lawsuits have outlined a series of problems and adverse events, including:

• Unsatisfactory pain relief
• Failure to achieve or maintain pain relief
• Sudden electrical shocks
• Burning or jolting sensations
• Increased back, leg or nerve pain
• New numbness or loss of sensation
• Weakness in the legs or feet
• Loss of balance or falls
• Difficulty walking
• Bowel or bladder incontinence
• Spinal cord nerve damage
• Muscle weakness
• Paralysis or paraplegia
• Lead migration
• Lead fracture or lead failure
• Battery or charging problems
• Device shutdown
• Loss of therapy
• Wireless communication problems
• Programming failure
• Device malfunction
• Unexpected or painful stimulation
• Infection
• Revision surgery
• Explant surgery to remove the device
• Reports associated with patient deaths

Many plaintiffs allege they were repeatedly told that reprogramming would correct the problem, only to continue experiencing shocks, pain, numbness, weakness or loss of therapy. Lawsuits claim these repeated programming attempts may have delayed removal of defective devices and caused some patients to live with worsening symptoms longer than necessary.

Abbott Trial Implant Allegations

Abbott spinal cord stimulator lawsuits allege the company and its representatives overstated how well permanent implants would perform after a temporary SCS trial.

Patients commonly undergo a temporary trial before receiving a permanent spinal cord stimulator. Lawsuits claim Abbott representatives promoted permanent Proclaim, Eterna and related SCS systems as long-term pain relief devices that would perform as well as, or better than, the temporary trial system.

Plaintiffs allege Abbott failed to adequately disclose that the permanent implant may not provide the same relief experienced during the trial, and that some patients could experience severe complications leading to painful revision or removal surgeries with worse outcomes.

Permanent vs. Trial Implant Problems

The lawsuits allege Abbott representatives and promotional materials overstated the expected benefits of permanent implantation by claiming the devices would:

• Provide long-term pain relief
• Perform as well as or better than the trial stimulator
• Be safe and clinically validated
• Reduce the need for other chronic pain treatments
• Improve symptoms after programming adjustments

Plaintiffs allege the permanent implants did not perform as represented. Some lawsuits further claim that patients were encouraged to report stronger results from the temporary trial than they actually experienced, so insurance would approve the permanent Abbott spinal cord stimulator implant.

Abbott Representative Programming Allegations

Abbott spinal cord stimulator lawsuits also focus on the company’s alleged role in post-implant device programming. Plaintiffs claim Abbott representatives were directly involved in programming and reprogramming devices after implantation, including after patients reported shocks, burning pain, numbness, weakness, loss of therapy or poor pain relief.

The lawsuits allege these representatives did more than provide general product support. Plaintiffs claim Abbott representatives made therapy adjustments, advised patients that additional reprogramming would correct complications, and influenced how electrical stimulation was delivered after the permanent device was implanted.

Reprogramming Issues Raised in Lawsuits

The Abbott lawsuits allege company representatives:

• Programmed devices immediately after permanent implantation
• Reprogrammed devices multiple times after patients reported complications
• Made therapy adjustments without meaningful physician supervision
• Told patients that reprogramming would correct pain, shocks or side effects
• Provided device-related advice outside a physician’s presence
• Were presented as the primary people responsible for adjusting the device
• Influenced how stimulation was delivered to the patient’s spine or nerves

Plaintiffs allege repeated reprogramming allowed device problems to continue while patients were directed back to Abbott representatives instead of being fully informed that the implant may have been malfunctioning or causing injury.

Evidence To Support an Abbott Spinal Cord Stimulator Lawsuit

Medical records and device records may be critical in determining whether an Abbott spinal cord stimulator claim can be pursued. Because Abbott’s product line includes multiple generations of devices and components, identifying the exact device and documenting the complications after implantation is important.

Potential evidence may include:

• Implant card showing the Abbott or St. Jude device model
• Operative report from the permanent implant surgery
• Records from the temporary spinal cord stimulator trial
• Device stickers, model numbers or serial numbers
• Follow-up notes from pain management visits
• Records of programming or reprogramming appointments
• Text messages or communications with Abbott representatives
• Imaging showing lead migration or hardware problems
• Records documenting shocks, numbness, falls or loss of therapy
• Revision surgery records
• Explant surgery records
• Records showing ongoing physical therapy, mobility problems or neurological symptoms

Allegations Raised in Abbott Spinal Cord Stimulator Lawsuits

Abbott spinal cord stimulator lawsuits claim Abbott and its predecessors sold substantially changed SCS systems without adequate testing, warnings or regulatory review to ensure they remained safe for patients. Lawsuits raise the following allegations:

• Failure to warn: Lawsuits claim Abbott failed to adequately warn patients and doctors about painful shocks, overstimulation, loss of therapy, device shutdown, battery problems, wireless communication failures, nerve damage, mobility problems and the possibility that a permanent implant would not perform like the temporary trial.
• Manufacturing defects: Plaintiffs allege some Abbott spinal cord stimulators contained defects involving firmware execution, wireless programming reliability, battery charging performance, waveform delivery or lead function, which may have caused painful stimulation, ineffective therapy, device malfunction or the need for revision surgery.
• Design defects: Lawsuits claim Abbott introduced substantial changes to newer SCS systems, including firmware-controlled stimulation, Bluetooth programming, rechargeable battery platforms and new waveform patterns, without adequate clinical testing to confirm the redesigned devices were safe and effective for long-term implantation.
• Negligence: Plaintiffs allege Abbott failed to use reasonable care when designing, testing, marketing, monitoring and updating its spinal cord stimulator systems, despite reports of serious complications and device malfunctions.
• Negligence per se: Some lawsuits claim Abbott violated federal medical device requirements, including obligations involving adverse event reporting, complaint handling, design validation, process validation and corrective action.
• Unauthorized practice of medicine: Plaintiffs allege Abbott representatives programmed or reprogrammed spinal cord stimulators, adjusted therapy settings and provided device-related advice without being licensed medical providers.
• Breach of warranty: Plaintiffs allege Abbott represented that its spinal cord stimulators were safe, effective, reliable, clinically validated and capable of providing long-term pain relief, when the devices allegedly failed to perform as promised.
• Misrepresentation or concealment: Lawsuits claim Abbott misrepresented or concealed material information about the safety, effectiveness, testing, recalls and regulatory history of its SCS systems.
• Consumer protection violations: Some claims allege Abbott used misleading marketing or promotional statements that caused patients and doctors to believe the devices were safer, better tested or more reliable than they actually were.

The lawsuits generally allege that patients and doctors relied on Abbott’s representations when agreeing to trial stimulation, permanent implantation and continued reprogramming after complications developed.

Abbott Spinal Cord Stimulator Lawsuit Compensation

Individuals who pursue an Abbott spinal cord stimulator lawsuit may be able to seek compensation for injuries and losses caused by the device. Potential damages may include compensation for:

• Medical expenses
• Revision surgery or explant surgery
• Corrective spinal procedures
• Pain and suffering
• Permanent nerve damage
• Mobility problems or paralysis
• Lost wages or reduced earning capacity
• Emotional distress
• Loss of enjoyment of life
• Future medical care
• Out-of-pocket treatment and rehabilitation expenses

The value of each claim will depend on the severity of the injuries, whether additional surgery was required, the length of time the device remained implanted and the long-term impact on the individual’s health and daily life.

Abbott Spinal Cord Stimulator Lawyers

The spinal cord stimulator lawyers at Saiontz & Kirk are reviewing claims for individuals who suffered serious complications after receiving Abbott pain management implants.

If you suffered shocks, burning pain, numbness, weakness, loss of therapy, battery problems, worsening nerve pain, device failure, revision surgery or explant surgery after receiving an Abbott spinal cord stimulator, you may be eligible to pursue a claim.

Contact our Abbott spinal cord stimulator lawyers today for a free consultation.

FIND OUT IF YOU QUALIFY FOR AN ABBOTT SPINAL CORD STIMULATOR LAWSUIT

Abbott Spinal Cord Stimulator Lawsuit FAQs

Is there an Abbott spinal cord stimulator lawsuit?

• Yes. Abbott spinal cord stimulator lawsuits are being pursued by individuals who suffered serious complications after receiving Abbott, St. Jude Medical or Advanced Neuromodulation Systems pain management implants.

Who qualifies for an Abbott spinal cord stimulator lawsuit?

• You may qualify for an Abbott spinal cord stimulator lawsuit if you received an Abbott SCS device and later suffered serious complications, such as shocks, burning pain, numbness, weakness, loss of therapy, walking problems, revision surgery or removal of the implant.

How much does it cost to hire an Abbott spinal cord stimulator lawyer?

• There are no upfront fees to have Saiontz & Kirk review an Abbott spinal cord stimulator lawsuit. The firm handles these claims on a contingency fee basis, which means there are no fees or expenses unless compensation is recovered.

How do I know if I have an Abbott, St. Jude or ANS spinal cord stimulator?

• Your device may be identified on an implant card, operative report, device sticker sheet, pain management records or programming records. Because Abbott acquired St. Jude Medical, and St. Jude previously acquired Advanced Neuromodulation Systems, older implants may appear in medical records under any of those names.

Can I file an Abbott spinal cord stimulator lawsuit if my device only stopped working?

• Possibly. Loss of therapy may support a claim if the device shutdown, battery issue, programming failure or wireless communication problem caused serious pain, additional treatment, loss of mobility, revision surgery or removal of the implant.

What should I do if my Abbott spinal cord stimulator is stuck in MRI mode?

• If your Abbott spinal cord stimulator appears to be stuck in MRI mode or stimulation therapy has stopped after an MRI-related setting change, contact your treating doctor or device clinic promptly. Patients should also document when therapy stopped, whether the controller could communicate with the implant and whether replacement or additional treatment was recommended.

Can an Abbott spinal cord stimulator cause numbness, weakness or trouble walking?

• Some lawsuits allege Abbott spinal cord stimulators caused or contributed to new numbness, weakness, balance problems, falls or difficulty walking after implantation. These symptoms may be important to document because they can indicate a more serious neurological complication than simple loss of pain relief.

Are Abbott Proclaim and Eterna spinal cord stimulator claims different from older Genesis claims?

• They may be. Lawsuits involving newer Abbott Proclaim, Proclaim DRG, Proclaim XR, Proclaim Plus and Eterna systems often focus on later design changes involving firmware, wireless control, BurstDR stimulation, rechargeable or non-rechargeable batteries and MRI mode issues, while older Genesis-related claims may involve different device history and component issues.

What records are important for an Abbott spinal cord stimulator lawsuit?

• Important records may include your implant card, trial stimulation records, permanent implant operative report, device model and serial numbers, programming notes, communications with Abbott representatives, imaging studies, fall or mobility records, revision surgery records and explant surgery records.

Can I bring a claim if Abbott representatives kept reprogramming my device?

• You may be able to bring a claim if repeated Abbott representative programming failed to resolve shocks, burning pain, loss of therapy, numbness, weakness or worsening pain. Records showing who adjusted the device, what settings were changed and whether a doctor was present may be important evidence.

How long do I have to file an Abbott spinal cord stimulator lawsuit?

• The deadline to file an Abbott spinal cord stimulator lawsuit depends on the statute of limitations in your state and when you discovered, or reasonably should have discovered, that your injuries may be linked to the device. Patients should speak with a lawyer promptly after serious complications, loss of therapy, revision surgery or removal of an Abbott spinal cord stimulator.