Spinal Cord Stimulator Lawsuit Claims Boston Scientific Sales Reps Made Unauthorized Device Adjustments

Woman alleges Boston Scientific device caused her to suffer dizziness and fainting as a result of random electric shocks and unexpected resets.

Boston Scientific faces a product liability lawsuit filed by a Louisiana woman who says that, instead of alleviating her pain, the manufacturer’s WaveWriter Alpha spinal cord stimulator caused her to suffer burning sensations and electric shocks, resulting in neurological injuries.

The complaint (PDF) was brought by Bridgette Venturi in the U.S. District Court for the District of Massachusetts on July 10. In addition to Boston Scientific, the lawsuit notes that other individuals and corporations may be added in the future as more information about the manufacturing process becomes available.

Venturi’s complaint joins a growing number of lawsuits, each alleging spinal cord stimulator sales representatives adjusted device settings without a doctor present, while manufacturers relied on aggressive sales personnel to perform programming or treatment-related tasks that should have been handled by licensed medical professionals.

Spinal Cord Stimulator Problems

Spinal cord stimulators are surgical implants placed along the spine to treat chronic pain. The devices use implanted electrodes and a battery-powered pulse generator, known as an IPG, to deliver electrical stimulation intended to interrupt pain signals before they reach the brain. Patients typically use an external remote control to adjust the level of stimulation.

In recent years, spinal cord stimulators made by several manufacturers have drawn concern following reports of device failures and serious complications, sometimes requiring additional surgery only months after implantation. Reported problems include battery failures, unexpected shutdowns, electric shocks, burning sensations, worsening pain, neurological injuries and leads that migrate out of position or push through the skin.

Spinal cord stimulator lawsuits allege manufacturers sold defective devices and failed to adequately warn patients and doctors about the potential risks. The claims seek compensation for medical expenses, revision or removal surgery, lost income, pain and suffering, permanent injuries and other damages caused by spinal cord stimulator complications.

WaveWriter Alpha Injury Allegations

Following a posterior fusion surgery, Venturi began suffering chronic pain that did not resolve, resulting in her receiving a WaveWriter Alpha spinal cord stimulator in October 2024. The procedure followed a trial period with a temporary device. She received the device just months after Boston Scientific issued an urgent medical advisory about problems with the product.

About seven months after implantation, Venturi indicates she began suffering severe burning and sharp electric shocks, which she could feel radiating from the pulse generator battery through her lower extremities. She also began experiencing dizziness and fainting several times per week, requiring her to avoid driving or other strenuous activities.

Additionally, she indicates that the WaveWriter Alpha did all of that without alleviating the very pain it was designed to treat. The lawsuit notes that the device often reset or experienced unexpected surges during routine system checks.

“These symptoms are consistent with moisture ingress into the sealed IPG enclosure, causing electrical shorts and unintended stimulation, as described herein and in Boston Scientific’s July 2024 urgent medical advisory.”

– Bridgette Venturi v. Boston Scientific Corporation et al.

Furthermore, Venturi’s complaint alleges Boston Scientific representatives were involved before, during and after implantation, including programming and adjusting the WaveWriter Alpha during follow-up visits. The lawsuit maintains that the company’s representatives went beyond providing technical support by supervising the device, influencing treatment decisions and making programming changes without adequate medical oversight.

More broadly, the complaint claims Boston Scientific failed to properly train and supervise its representatives or ensure that medical decisions remained with licensed healthcare providers. Venturi alleges this unauthorized involvement allowed representatives to continue recommending device adjustments while her symptoms persisted, delaying consideration of removal or other medical treatment.

Her lawsuit presents claims of manufacturing defect, failure to warn, strict product liability, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, and violations of Massachusetts Business Practices for Consumers Protection Act, and the Louisiana Unfair Trade Practices and Consumer Protection Law. It seeks both compensatory and punitive damages.

Spinal Cord Stimulator Lawsuits

Venturi’s complaint will be consolidated with other 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.

Judge Staton is expected to order the parties to prepare several representative cases for eventual early test trials. These “bellwether” trials are designed to give attorneys for both sides a preview of how juries are likely to process evidence and testimony that would be repeated throughout most of the litigation.

The Boston Scientific bellwether trials could also be a guide for future spinal cord stimulator lawsuits, which several other manufacturers also face, including Abbott Laboratories and Nevro.

Spinal cord stimulator lawyers are currently investigating claims for individuals who received an Abbott, Boston Scientific, Nevro or Medtronic SCS and 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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