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.

Manufacturers like Boston Scientific are facing a growing number of spinal cord stimulator lawsuits from individuals claiming that the devices were marketed and cleared under older regulatory approvals despite being substantially modified, and that the failures have led to issues such as lead migration, unpredictable stimulation and revision surgeries.

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.

Spinal Cord Stimulator Lawsuit Criteria

Individuals who received a spinal cord stimulator from manufacturers such as Abbott, Boston Scientific, Medtronic, or others and later experienced serious complications may be eligible to pursue an SCS lawsuit. Lawsuits may involve claims related to:

• Revision surgery to reposition or replace device components
• Complete removal (explant) of a spinal cord stimulator
• Permanent nerve damage or neurological injury
• Worsening or uncontrolled pain after implantation
• Infections or other serious post-surgical complications
• Device failures involving leads, batteries, charging, or power delivery
• Long-term disability or loss of quality of life
• Deaths potentially linked to complications from implanted spinal cord stimulators

Spinal cord stimulator lawyers are handling cases on a contingency-fee basis, meaning there are no upfront costs and attorney fees are paid only if compensation is recovered through a settlement or trial verdict.

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