Lawsuit Claims Spinal Cord Stimulator Battery Problems Resulted in Removal of Boston Scientific Device

Man claims his Boston Scientific spinal cord stimulator malfunctioned due to potential battery issues, forcing repeated reprogramming attempts that allegedly failed to control pain or prevent shocking sensations.

A Florida man has filed a lawsuit alleging that battery-related problems with a spinal cord stimulator manufactured by Boston Scientific caused severe complications that ultimately required the implanted medical device to be permanently removed from his body.

The complaint (PDF) was brought by Brian Martini in the U.S. District Court for the Central District of California on January 27, naming Boston Scientific Corporation and the U.S. Food and Drug Administration (FDA) as defendants.

Spinal cord stimulators are implantable medical devices designed to manage chronic pain by delivering electrical impulses to the spinal cord, which are intended to interfere with pain signals before they reach the brain. The systems typically include thin wires, known as leads, placed near the spinal cord and a battery-powered pulse generator implanted under the skin, often near the lower back or buttocks. Patients can adjust stimulation levels using an external controller.

However, manufacturers like Boston Scientific are increasingly being named in spinal cord stimulator lawsuits being brought by individuals who allege the devices were promoted and allowed to remain on the market under outdated regulatory clearances after significant design changes. Many of the lawsuits claim that those products later failed in ways that caused lead movement, erratic stimulation and the need for additional corrective or removal surgeries.

According to the complaint, Martini underwent implantation of a Boston Scientific spinal cord stimulator in November 2018 to treat chronic pain after being told the device would provide reliable, long-term relief. Instead, he alleges the system caused worsening symptoms, including pain and electric shock sensations, due to battery and programming failures.

The lawsuit identifies the device as a Precision Montage MRI spinal cord stimulator and claims it suffered from instability and performance problems tied to its battery and internal programming. Martini alleges he underwent repeated reprogramming sessions by company representatives in an effort to address severe pain and ineffective therapy, but the adjustments failed to provide lasting relief.

The complaint further alleges that the device’s battery abnormally overheated while charging, forcing Martini to undergo an additional surgery in June 2020 to relocate the battery due to persistent pain at the implant site. Despite these interventions, the lawsuit claims the device continued to malfunction, ultimately leading to explant surgery in 2022 and resulting in long-term nerve damage.

Spinal Cord Stimulator Injuries

In February 2022, Martini allegedly underwent surgery to permanently remove the spinal cord stimulator after it failed to provide adequate pain relief and caused lasting neurological injuries. He claims that he continues to suffer chronic pain and nerve damage even after the device was explanted.

The lawsuit raises broader allegations about the safety and regulatory oversight of Boston Scientific’s spinal cord stimulator systems, stating that the company introduced substantial design and battery architecture changes to its devices over time without conducting new clinical trials to confirm long-term safety and effectiveness. The complaint suggests that battery instability, stimulation failures and device migration were known risks that were not adequately disclosed to patients or physicians.

Martini also alleges that Boston Scientific sales representatives were heavily involved in programming and managing his device both during and after implantation, despite not being licensed medical professionals. The complaint claims that those representatives provided medical advice and reassurances that led him to keep the device implanted longer than he otherwise would have, worsening his injuries.

The lawsuit goes on to challenge the FDA’s approval process for the device, indicating that regulators improperly allowed major design changes through supplemental filings without requiring new premarket approval (PMA).

“Plaintiff’s injuries, including physical pain, emotional distress, surgical trauma, loss of enjoyment of life, and the permanent implantation of defective hardware, were directly and proximately caused by the acts and omissions of Boston Scientific, as well as the FDA’s unlawful and arbitrary failure to require a new PMA for the substantially modified Precision Montage MRI device.”

— Brian Martini v. Boston Scientific Corporation et al

Martini raises allegations of manufacturing defect, failure to warn, negligence, breach of express and implied warranties, fraudulent misrepresentation, negligent misrepresentation, violations of the California Unfair Competition Law and negligence for practicing medicine without a license against Boston Scientific. He is also challenging the FDA Administrative Procedure Act.

The lawsuit is seeking compensatory, statutory and punitive damages for medical expenses, pain and suffering, lost income and diminished quality of life, as well as declaratory and injunctive relief related to the FDA’s actions.

Spinal Cord Stimulator Lawsuits

This complaint joins a series of spinal cord stimulator lawsuits brought by individuals who received one of these devices from major manufacturers such as Boston Scientific, Abbott, Medtronic or others, and later suffered serious complications, including:

• 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 lawsuits are being pursued for individuals on a contingency-fee basis, meaning there are no upfront costs, and attorney fees are only paid if compensation is obtained through a settlement or trial verdict.

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