Boston Scientific Spectra WaveWriter Lawsuit Alleges Lead Fracture, Migration and Painful Electric Shocks

Lawsuit claims symptoms reported in spinal cord stimulator lawsuits and recalls are identical to problems caused by moisture ingress.

A South Carolina woman has filed a product liability lawsuit alleging Boston Scientific spinal cord stimulator implants may frequently fail because of poor manufacturing that allows moisture to damage their delicate electronics.

The complaint (PDF) was brought by Theresa Donner in Massachusetts Superior Court on October 14, naming Boston Scientific Corporation and other unknown entities as the defendants.

Donner claims the manufacturer failed to construct a proper hermetic seal for the spine implants’ components, causing corrosion, short circuits and device failure. As her device failed, Donner allegedly experienced random electric shocks, a return of chronic pain, having to reset the device multiple times and unexpected surges of stimulation.

She states the implant was manufactured with defective welds or seals, which Boston Scientific’s quality control department failed to catch.

Spinal Cord Stimulator Injuries

Spinal cord stimulators (SCS) use electrical pulses to try to block pain signals from reaching the brain. They consist of a battery-powered pulse generator and leads, which are implanted near the spine, and an external remote control for changing and setting the stimulation settings.

Designed to be permanent implants, Boston Scientific, Abbott Laboratories, Nevro and Medtronic all face a growing number of spinal cord stimulator lawsuits from individuals who have experienced device failures resulting in permanent nerve damage and other injuries.

These spinal cord stimulator problems frequently require patients to go through another surgery to have the implants removed. Consumers often say the manufacturers knew or should have known about the potential risks and either warned them or made the necessary design changes to prevent injuries and device failures.

Spinal Cord Stimulator Failure Allegations

According to the complaint, Donner was first implanted with a Boston Scientific Spectra WaveWriter SCS in November 2019. She hoped the implant could provide her with relief after a history of back pain.

However, problems allegedly began six months after implantation, starting with sharp electric shocks radiating out from the battery site. These occurred between once per day and once every other day, the complaint notes.

Problems continued to worsen over time, leading to fracture or migration of components, loss of pain-management efficacy, and the need to repeatedly reset the device, which caused painful surges every time, among other problems.

“These symptoms are consistent with moisture ingress into the sealed IPG enclosure, causing electrical shorts and unintended stimulation, as described herein. Due to the issues that Plaintiff experienced, she elected to have the System explanted on or about August 5, 2026. Plaintiff continued to experience painful symptoms for approximately one year after the System was removed and continues to suffer lasting injuries.”

– Theresa Donner v. Boston Scientific Corporation Inc. et al.

Any device being implanted into the human body must be hermetically sealed so that no moisture or fluids can penetrate the device and get to the electronics. The most crucial areas are the joints, which must be precisely laser-welded, and feedthroughs, where wires go into and out of the device.

The Spectra WaveWriter lawsuit notes that Donner’s symptoms, as well as symptoms described in several past Boston Scientific SCS implant recalls, are the exact type of results one would expect from moisture ingress.

Donner argues that moisture entering an active implanted stimulator can disrupt electrical currents and cause excessive heat or unintended stimulation, potentially resulting in direct injuries to patients.

The lawsuit presents claims of manufacturing defect and negligence. It seeks both punitive and compensatory damages.

Boston Scientific SCS System Lawsuits

Dozens of Boston Scientific SCS implant lawsuits have been consolidated before U.S. District Judge Josephine Staton in the Central District of California. The judge has begun taking the litigation through coordinated discovery and pretrial proceedings in preparation for a series of early test “bellwether trials”.

Spinal cord stimulator lawyers continue to review potential claims nationwide of SCS implant stimulator problems and failures, resulting in complications including:

Individuals who experienced complications potentially linked to a defective SCS implant can request a free evaluation to determine whether they may be eligible to pursue a spinal cord stimulator lawsuit. Attorneys investigating these cases handle claims on a contingency fee basis, with no upfront legal fees and payment only if compensation is recovered.

Sign up for more legal news that could affect you or your family.