Boston Scientific Spinal Cord Stimulator Lawsuit Claims Lead and Battery Problems Led to Multiple Revision Surgeries

Lawsuit indicates Boston Scientific sales representatives repeatedly met with patient without doctors present to sell and defend the implant.

A Virginia patient implanted with a Boston Scientific spinal cord stimulator has filed a lawsuit alleging the device is prone to migration and other problems, which federal regulators should have caught before allowing it on the market.

The complaint (PDF) was brought by Ollie Wilson in the U.S. District Court for the Central District of California on October 17, naming Boston Scientific Corporation and the U.S. Food and Drug Administration (FDA) as defendants.

Spinal cord stimulators (SCS) are implantable medical devices used to manage chronic pain by delivering mild electrical impulses to the spinal cord, interrupting pain signals before they reach the brain. 

The Boston Scientific SCS system was first approved by the U.S. Food and Drug Administration (FDA) in 2004, and has since undergone numerous design changes and software updates through the agency’s premarket approval process.

However, the lawsuit claims the FDA failed to properly evaluate these subsequent versions, allowing significantly modified devices to reach patients under the original 2004 approval. The complaint alleges this violated the Administrative Procedure Act, and reflects a broader failure to ensure the updated stimulators were safe and effective before being released to the public.

According to the lawsuit, Wilson received a Boston Scientific spinal cord stimulator in 2022 to treat chronic pain, which included a WaveWriter Alpha implantable pulse generator along with accompanying leads and anchoring components.

“In the two years after the SCS system was implanted, Plaintiff experienced worsening symptoms, including ineffective stimulation, nerve pain, unpredictable shocking sensations, lead migration, difficulty with programming of the SCS system, painful revision surgeries due to lead migration and the SCS battery flipping, and a return of severe baseline pain.”

– Wilson v Boston Scientific Corporation et al

The lawsuit indicates Boston Scientific sales representatives repeatedly met with Wilson when doctors were not around, providing reassurance that it was impossible for the SCS to cause the types of problems experienced. However, in November 2023, Wilson required revision surgery due to the device’s leads, the electrodes that deliver the electrical pulses to the spine, migrating out of position.

A second surgery was performed in May 2024 after doctors discovered the SCS battery had flipped inside its pocket. By December 2024, the device was removed entirely after physicians determined it was no longer functioning or providing any therapeutic benefit.

The complaint indicates that the repeated changes made to the implant’s design made it fundamentally different from the original device approved in 2004, and that the FDA should have required new approvals, yet failed to do so.

As a result, Wilson is presenting claims against Boston Scientific of manufacturing defect, failure to warn, negligence per se, breach of warranty, fraudulent misrepresentation, negligent misrepresentation, and violations of the California Unfair Competition Law, in addition to a claim against the FDA, seeking declarative and injunctive relief under the Administrative Procedure Act.

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