Proclaim Spinal Cord Stimulator Lawsuit Follows Infection, Battery Migration

Doctors discovered leads and battery trying to push through plaintiff’s skin, after bleeding from the wound soaked through bandages and ruined two mattresses.

A product liability lawsuit alleges the defective design of the Abbott Proclaim XR5 spinal cord stimulator resulted in the battery migrating out of position in a Texas man’s back and causing a potentially life-threatening infection.

Daymond Williams filed the complaint (PDF) in the U.S. District Court for the Northern District of Texas on June 25. Both Abbott Laboratories and the U.S. Food and Drug Administration (FDA) are named as defendants.

According to the lawsuit, Abbott was able to sneak a defective design past the FDA by using a fast-track approval program that did not require clinical trials or any evidence the devices were actually safe and effective. The lack of enforcement then allowed the manufacturer to avoid adding label warnings that may have led some doctors and patients to reconsider the aggressively marketed devices.

Spinal Cord Stimulator Failure Risks

Spinal cord stimulators are surgically implanted devices used to treat chronic pain by disrupting pain signals before they reach the brain. The systems typically include electrodes placed near the spine, a battery-powered pulse generator implanted under the skin, and an external remote used to adjust stimulation levels. Although they may be removed or replaced, spinal cord stimulators are generally intended to function as long-term implants.

However, despite marketing heralding the devices as effective at controlling pain for those who have not benefited from other treatments, a growing number of consumers are reporting problems with the devices, with many having them surgically removed just months after implantation. These reports include battery problems, electric shocks, burning sensations, increases in chronic pain, unexpected shutdowns and leads migrating out of position or poking through the skin.

As reports continue to pour in, they have been accompanied by a growing number of spinal cord stimulator lawsuits filed in federal courts nationwide, each involving similar claims that both the manufacturers and the FDA failed to adequately test the devices before they were placed on the market, resulting in a defective design that can cause severe, life-altering injuries.

Williams’ complaint indicates that he was surgically implanted with an Abbott Proclaim XR5 SCS in August 2021. The decision to have the device placed near his spine came after he had undergone a trial period with a temporary spinal cord stimulator, which was supposed to ensure the therapy would be effective.

The lawsuit states that Williams had questions about the device’s effectiveness, but he was reassured by Abbott sales representatives that the permanent implant would be more effective, and that he needed to say the device gave him at least 50% relief or his insurance would not cover the cost.

Feeling pressured, Williams states that he complained to the sales representative. He met with the representative and was advised that the permanent version of the Proclaim XR5 would safely provide him with the pain relief he desired.

Succumbing to the aggressive marketing tactics and allegedly misleading promotions, Williams agreed to have the procedure.

In June 2024 is when problems began, according to the complaint. It began with increasing discomfort and Williams’ back beginning to bleed and ooze profusely. He claims the bleeding was heavy enough to soak through any bandage and ruined two separate mattresses.

Williams went to a nearby emergency room, where doctors determined that Williams had developed some type of cyst near the implant site. His own doctor thought it might be cancer. After the two medical misdiagnoses, a dermatologist and neurosurgeon linked the injury back to the Proclaim spinal cord stimulator.

In October 2024, Williams had to undergo immediate revision surgery to have the spinal cord stimulator removed.

“This removal was necessitated due to an infection caused by the spinal stimulator’s leads and battery migrating from their original position and attempting to exit Plaintiff’s back. This infection threatened meningitis and was killing the tissue in his back.”

– Daymond Williams v. Abbott Laboratories et al.

Williams presents claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, unauthorized practice of medicine, violation of the Texas Deceptive Trade Practices Consumer Protection Act, and violation of the Administrative Procedure Act. He seeks both compensatory and punitive damages.

Spinal Cord Stimulator Lawsuits

The complaint joins a series of Abbott Laboratories spinal cord stimulator lawsuits that are proceeding separately in federal courts nationwide. Plaintiffs previously sought to centralize the cases before one judge to coordinate discovery, avoid conflicting pretrial rulings and make the litigation more efficient. However, the U.S. Judicial Panel on Multidistrict Litigation ruled earlier this month that the Abbott claims do not need to be consolidated for coordinated pretrial proceedings.

The panel reached a different conclusion for Boston Scientific spinal cord stimulator lawsuits, which have been centralized in the Central District of California before U.S. District Judge Josephine L. Staton for coordinated discovery and pretrial proceedings.

Despite the different tracks of litigation, spinal cord stimulator lawyers continue to investigate claims for individuals who received an Abbott, Boston Scientific, Nevro or Medtronic SCS that suffered any of the following injuries:

To find out whether you or a loved one may qualify for a spinal cord stimulator lawsuit, submit information to receive a free case review by a lawyer. All claims are handled on a contingency fee basis, which means there are no fees or expenses unless a recovery is obtained.

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