The Sentinel Group
The Sentinel Group

Spinal Cord Stimulators and Serious Device Injuries

If you received a Spinal Cord Stimulator (SCS) implant and experienced burns, electric shocks, lead wire failure, or other serious complications, you may be entitled to compensation.

In early 2026, plaintiffs across the country began seeking consolidation of federal lawsuits targeting Abbott and Boston Scientific spinal cord stimulators, with cases alleging that these devices were defectively designed and that patients were never adequately warned about the risks. The litigation centers on allegations that manufacturers made sweeping design and firmware changes to their devices over the years, sometimes hundreds of modifications, without properly updating physicians or patients about the new dangers those changes created.

Mounting legal complaints and FDA safety reports have begun to reveal a troubling pattern of device-related injuries tied to spinal cord stimulators. SCS devices are small implants placed near the spinal cord and designed to reduce chronic pain by interrupting nerve signals before they reach the brain. However, for a growing number of patients, the devices have caused new and serious harm rather than relief. Common injuries reported in connection with SCS devices include:

  • Burning sensations caused by the device
  • Electric shocks from the device
  • Lead wire fracture or migration
  • Urinary incontinence or retention
  • Gastroparesis
  • Dysphagia (difficulty swallowing)
  • Uncontrollable diarrhea
  • Dizziness or fainting
  • Ineffective pain relief or worsening pain
  • Cardiac arrhythmia
  • Inability to receive future MRI scans

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Find Out If You Qualify for a Spinal Cord Stimulator Lawsuit

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SCS Device Failures: What the Evidence Shows

Lawsuits filed in 2025 and 2026 allege that major SCS manufacturers, including Abbott and Medtronic, exploited the FDA’s PMA supplement process to push through hundreds of hardware and firmware changes to their devices without returning for full regulatory review and without disclosing new risks to physicians or patients.
In one high-profile complaint, an Arizona man alleged that one day after his Abbott Proclaim Plus 5 stimulator was implanted, the device shocked him and he felt a “pop” in his back. Over the following months, he allegedly lost the use of his legs entirely, progressing from a cane to a wheelchair before becoming paralyzed from the waist down by late 2024.
A separate lawsuit targeting Abbott’s Proclaim XR5 system alleged that a patient experienced repeated lead migration, underwent multiple revision surgeries, and ultimately had the device removed after it lost all therapeutic effectiveness, while Abbott sales representatives, rather than physicians, were the primary people managing device programming after implantation.
Plaintiffs’ attorneys have also argued that companies like Medtronic cannot invoke federal preemption as a defense when the regulatory approvals they rely on were obtained through regulatory maneuvering rather than genuine compliance.

SCS Devices and FDA Oversight: What Patients Should Know

Spinal cord stimulators are classified as Class III medical devices, the highest-risk category, and must go through the FDA’s Premarket Approval (PMA) process before reaching patients. This review is intended to ensure safety and effectiveness. However, once a device is approved, manufacturers can make modifications through a supplemental pathway that does not always require the same level of scrutiny as the original approval.
Critics and plaintiffs allege this system has been systematically abused, with some manufacturers accumulating more than 200 supplemental changes to a device’s core design, software, and hardware while continuing to market it under the authority of a much older approval. Despite being marketed heavily for chronic back and spine pain, SCS devices carry real risks that many patients say they were not adequately counseled about before surgery.

What You Should Know About SCS Injuries and Your Legal Rights

Spinal cord stimulators are implanted in hundreds of thousands of patients annually in the United States, marketed as a minimally invasive alternative to long-term opioid use or repeat spine surgeries. But when these devices fail, the consequences can be severe and lasting.
Device Malfunction and Repeat Surgery
Many patients who experience lead migration, hardware failure, or loss of therapeutic effectiveness are forced to undergo painful revision surgeries or full device removal procedures that carry their own risks of infection, nerve injury, and prolonged recovery.
Worsening Pain and New Symptoms
Rather than improving a patient’s quality of life, a failing SCS device may introduce entirely new symptoms. Reports of burning, electric shocks, bladder dysfunction, and GI complications appear frequently in FDA adverse event databases and in litigation filed nationwide.
Manufacturer Accountability
Lawsuits allege that SCS manufacturers not only sold defective devices but also actively misled patients and physicians about their safety profile and continued making undisclosed design changes after initial approval. In some complaints, company sales representatives, not physicians, are accused of managing device settings and discouraging patients from recognizing that their implant was failing.

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Our network of attorneys have been helping individuals, like you, for years.

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Do I Have A Case

If your Spinal Cord Stimulator caused serious injury, you may be entitled to financial compensation.

Experienced Attorneys

Our legal team has extensive experience holding device manufacturers accountable.

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Contact us today for a free, confidential, and no-obligation case review. We’re ready to fight for you.

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