Abbott's Proclaim and Eterna SCS Systems: Defect Allegations
Abbott Laboratories (which acquired St. Jude Medical in 2017 for $25 billion) faces class action and individual product liability lawsuits over its spinal cord stimulator (SCS) systems, particularly the Proclaim XR and Eterna platforms. Spinal cord stimulators are implanted electronic devices that deliver mild electrical impulses to the spinal cord to interrupt pain signals, used as a last-resort treatment for chronic back, leg, and neck pain when other interventions have failed. Abbott is one of the Big Three SCS manufacturers alongside Medtronic and Boston Scientific.
The specific defect allegations involve: premature battery depletion requiring earlier-than-expected replacement surgeries; software errors causing unexpected stimulation pattern changes that worsened patient pain rather than relieving it; lead migration and fracture problems causing stimulation failure; and charging system failures in the rechargeable models that left patients without functional pain control. Consulting product liability attorneys can help evaluate your specific claim. Each of these failure modes potentially requires a revision surgery (with all the risks, costs, and recovery that entails) for a device that was implanted specifically because the patient had exhausted safer pain management options.
FDA MDRs and the Warning History
Medical Device Reports (MDRs) filed with the FDA (mandatory reports of device malfunctions and patient injuries) document thousands of reports associated with Abbott SCS systems. Abbott has issued multiple Field Safety Corrective Actions (FSCAs) and safety notices, including a 2022 notice regarding specific firmware issues in certain Proclaim devices. These regulatory submissions establish that Abbott was aware of device performance issues and chose remediation paths short of full recall.
The failure-to-recall theory is a significant component of the litigation: when a known, systematic device defect causes repeated patient harm, the legal standard may require a full market withdrawal rather than a targeted software update or patient notification. Plaintiffs argue Abbott chose less disruptive remedies to protect its market position and revenue stream while leaving defective devices implanted in patients who deserved replacement. Related: general SCS defect claims overview.
Who Has an Abbott SCS Claim?
Patients who received Abbott (St. Jude Medical) spinal cord stimulators and experienced device failures requiring revision surgery, unanticipated stimulation changes that worsened their condition, or battery failures requiring premature replacement may have viable product liability claims. The strongest cases involve: documented device malfunction in medical records, a revision surgery directly attributable to the device failure, and economic damages including surgical costs and ongoing care expenses. Medical device implant records, post-operative notes, and device interrogation reports from programmer downloads are the core evidence.
How to File a Claim or Get Help
If you believe you qualify based on the eligibility criteria outlined above, the next step is a free consultation with an experienced attorney who handles this case type. Most plaintiff-side attorneys offer no-cost initial evaluations and work on contingency, meaning you pay nothing unless your case results in a recovery. Bring any relevant documentation to your consultation: receipts, medical records, correspondence, or any evidence of the harm you experienced.
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Is the Abbott Spinal Cord Stimulator Lawsuit Legitimate? Key Insights: Frequently Asked Questions
Answers to the most common questions about this case and your legal options.
Which Abbott SCS devices are involved in the lawsuit?
The litigation targets Abbott's (formerly St. Jude Medical) Proclaim XR, Proclaim Elite, Eterna, and related spinal cord stimulator platforms. These rechargeable and non-rechargeable devices cover Abbott's modern SCS product line. Check your device implant card or contact Abbott's medical information line to confirm your device model.
What is a spinal cord stimulator and how can it malfunction?
A spinal cord stimulator is a surgically implanted device with electrodes placed near the spinal cord, a lead wire, and a battery-powered pulse generator implanted under the skin. Malfunctions include: battery depletion faster than expected, lead fracture or migration from the original placement, software errors causing incorrect stimulation, and charging failures in rechargeable models, any of which can fail to control pain or worsen it.
Does SCS device failure require another surgery?
Usually yes, when an implanted SCS fails, the remediation options are limited to non-surgical programming changes (possible for software issues) or revision surgery to replace components. Battery failure, lead fracture, and hardware malfunctions typically require at least partial surgical revision. These revision surgeries carry infection and complication risks for already-compromised patients.
What damages can I claim for a defective Abbott SCS?
Damages include: revision surgery costs and associated medical expenses, lost wages during recovery, ongoing pain management costs if the device failure worsened your underlying condition, and non-economic damages for pain and suffering. Punitive damages may apply if Abbott's conduct in suppressing recall information was particularly egregious.
How do I get my Abbott SCS implant records?
Contact your implanting facility's medical records department for operative reports, device labels (which include model and serial number), and post-operative programming session records. Your primary care or pain management physician may also have device interrogation reports. Abbott maintains device registration records that your attorney can subpoena.
Legal Disclaimer
This article is for general informational purposes only and does not constitute legal advice or create an attorney-client relationship. Lawsuit eligibility, settlement amounts, and case status are subject to change as litigation develops. Always consult a licensed attorney in your jurisdiction before making legal decisions. LawsuitWatch is an independent journalism publication and is not a law firm. LawsuitWatch may receive referral compensation from affiliated legal service providers, which does not influence editorial content.