Lawsuit Indicates Spinal Cord Stimulator Lead Complications Resulted in Shocks, Removal Surgery

Complications from the spinal cord stimulator leads required surgery where the doctors had to cut through bone, causing the plaintiff to suffer heart problems.

An Arizona man has filed a product liability lawsuit stating that problems with his spinal cord stimulator leads caused heart problems, pain, fainting and additional surgeries to remove the failed back pain implant.

The complaint (PDF) was brought by Ethan Schwartz in the U.S. District Court for the District of Arizona on May 28, naming Abbott Laboratories, the manufacturer, as the sole defendant.

Schwartz’s claim now joins a growing number of spinal cord stimulator lawsuits being pursued against Abbott and other manufacturers, each raising similar allegations that the leads may be prone to fail and cause severe injuries.

Spinal Cord Stimulator Malfunction Risks

Spinal cord stimulators are medical implants designed to manage chronic pain. They are made of a small, battery-powered pulse generator that is placed under the skin, thin electrodes implanted near the spinal cord and connected to the generator, and a remote control for adjusting stimulation levels to maximize pain relief. Designed to be a permanent implant, spinal cord stimulators work by interfering with pain signals before they reach the brain.

For years, multiple medical device manufacturers have claimed that spinal cord stimulators are safe and effective. However, those assertions have come under doubt with a growing number of reports of device failures, worsening pain, electric shocks, problems with leads migrating out of position and other complications.

Spinal Cord Stimulator Lead Problem Allegations

This recently filed lawsuit indicates Schwartz was surgically implanted with a permanent spinal cord stimulator in May 2018. While he first went through a trial period with a temporary implant to see if it worked, Schwartz indicates he was encouraged to overstate the effectiveness of the pain relief by a company sales representative, who said it would help get his insurance to cover the costs.

However, the permanent implant led to worsening pain, electric shocks, numbness in his extremities, fainting, atrial fibrillation and other heart problems.

In June of 2024, doctors determined that there were problems with the spinal cord stimulator leads and indicated the implant had to be surgically removed. During the surgery, doctors had to cut bones to remove the defective leads, and Schwartz suffered a cardiac event.

It was only after the surgery that Schwartz began to learn about the large number of spinal cord stimulator lead problems being experienced by users, which the complaint indicates the manufacturer intentionally downplayed to increase profits at the expense of patients.

“Abbott’s conduct was knowing, deliberate, and reckless. It knowingly placed a materially altered medical device into the stream of commerce, misrepresented its safety and approval status, and failed to correct known defects through regulatory pathways available under federal law.”

— Ethan Schwartz v. Abbott Laboratories

The lawsuit states that until he became aware of other patients’ problems, Schwartz thought his injuries were an aberration unique to himself.

Schwartz presents claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment and violation of consumer protection laws. He seeks both compensatory and punitive damages.

Spinal Cord Stimulator Lead Lawsuits

The complaint may eventually be consolidated with similar spinal cord stimulator lead lawsuits being filed nationwide. In April, a group of plaintiffs petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all spinal cord stimulator claims involving Abbott and its competitor, Boston Scientific, before one judge in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

However, the manufacturers have asked the panel to reject the request, arguing that the various lawsuits do not identify a specific, common defect across multiple products, while also arguing that the litigation is too far along for consolidation to provide any benefits.

As more lawsuits are being filed against Abbott, Boston Scientific and other SCS manufacturers, spinal cord stimulator injury attorneys continue evaluating claims for individuals who experienced serious complications, including:

• Lead wire fractures or migration
• Painful electrical shocks or overstimulation
• Unexpected loss of pain relief
• Increased back pain or worsening nerve symptoms
• Revision procedures or surgical device removal
• Permanent nerve injuries
• Long-term spinal cord damage

All spinal cord stimulator injury lawsuits are handled on a contingency fee basis, meaning there are no upfront costs and legal fees are only collected if compensation is recovered through a settlement or trial verdict.

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