Abbott Spinal Cord Stimulator Explant Surgery Required After Device Failure: Lawsuit

A series of lawsuits similarly allege manufacturers such as Abbott, Boston Scientific and others failed to warn about device problems that often require recipients to undergo spinal cord stimulator removal surgery.

A South Carolina woman has filed a product liability lawsuit alleging an Abbott spinal cord stimulator caused painful electrical shocks, burning sensations and worsening pain before the device ultimately had to be removed.

The complaint (PDF) was brought by Leah Shaw in the U.S. District Court for the Southern District of Florida on August 28, naming Abbott Laboratories as the sole defendant.

Shaw alleges her Abbott Proclaim spinal cord stimulator suffered mechanical and therapeutic failures, including lead migration, resulting in explant surgery less than two years after the permanent device was implanted.

Spinal Cord Stimulator Problems

Spinal cord stimulators are implantable medical devices used to treat chronic pain by delivering electrical impulses near the spinal cord, which are intended to interrupt or alter pain signals before they reach the brain. The systems typically include an implanted pulse generator, electrical leads positioned near the spine and an external controller used to adjust stimulation settings.

However, a series of spinal cord stimulator problems and complications have been associated with the devices, including lead migration, battery problems, infections, painful electrical stimulation, loss of therapy and device failures that may ultimately require explant surgeries to remove or replace the implant.

Amid these concerns, spinal cord stimulator lawsuits allege manufacturers made substantial changes to newer generations of the devices through FDA regulatory pathways without conducting adequate new clinical testing to determine whether the modified systems remained safe and effective. Many Abbott spinal cord stimulator lawsuits maintain the manufacturer failed to adequately test its devices or warn doctors and recipients about the risk of malfunctions, painful stimulation, loss of therapy and the need for revision or removal surgery.

Some claims also focus on the role of Abbott representatives before and after implantation, alleging they overstated the potential benefits of permanent spinal cord stimulation, minimized known risks and made programming changes despite lacking the medical qualifications necessary to provide clinical treatment.

Abbott Spinal Cord Stimulator Explant Surgery

Shaw indicates she received an Abbott Proclaim Implantable Pulse Generator DRG, Model 3664, on May 7, 2021, at North County Surgicenter in Palm Beach Gardens, Florida, after first undergoing a temporary spinal cord stimulator trial.

According to the complaint, an Abbott representative told Shaw the permanent device would provide long-term pain relief, perform similarly to the trial system and reduce her need for other chronic pain treatments. Shaw alleges she relied on those representations when she agreed to permanent implantation.

However, Shaw says the device instead caused sudden electrical shocks, burning sensations, increased pain and painful “pops.”

The complaint alleges Abbott representatives repeatedly programmed and adjusted the spinal cord stimulator after implantation, at times without meaningful physician supervision. Despite those efforts, Shaw says the problems continued and the device’s leads eventually migrated from their intended position, leaving them displaced and nonfunctioning.

Shaw underwent explant surgery on April 28, 2023, less than two years after implantation, due to what the complaint describes as “mechanical and therapeutic failure” of the system.

She alleges the removal did not resolve all of her symptoms and that she continues to experience pain caused or aggravated by the malfunctioning implant.

“Plaintiff’s injuries were not caused by a known or disclosed risk; rather, they stemmed from a defect in the execution of the product’s firmware and power management systems, which were neither tested nor monitored in accordance with binding federal regulations.”

— Leah Shaw v. Abbott Laboratories

The lawsuit raises allegations of manufacturing defects, failure to warn, negligence, breach of express and implied warranties, negligent misrepresentation, fraudulent concealment and violations of consumer protection laws. It seeks compensatory damages for her physical injuries, pain and suffering, emotional distress, medical expenses and loss of enjoyment of life, as well as punitive damages and other relief.

Spinal Cord Stimulator Lawsuits

Shaw’s lawsuit comes amid a growing number of lawsuits being pursued against Abbott Laboratories and other spinal cord stimulator manufacturers, alleging patients experienced painful electrical shocks, lead migration, worsening pain and device failures that sometimes required spinal cord stimulator removal surgery.

In addition to claims against Abbott, all federal Boston Scientific spinal cord stimulator lawsuits have been consolidated before U.S. District Judge Josephine L. Staton in the Central District of California. Similar claims involving device malfunctions and serious complications are also being pursued against Medtronic and Nevro, with a hearing scheduled this month to consider separate requests to consolidate Abbott and Nevro spinal cord stimulator lawsuits.

Spinal cord stimulator attorneys are currently reviewing potential claims involving Abbott, Boston Scientific, Nevro and Medtronic devices for individuals who experienced complications such as:

Individuals who experienced serious complications after receiving an SCS implant may be eligible to pursue a spinal cord stimulator lawsuit seeking financial compensation. Potential claims are reviewed at no cost and handled on a contingency fee basis, meaning attorneys receive payment only if a settlement or other financial recovery is obtained.

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