Medtronic Spinal Cord Stimulator Lawsuit Filed Over Unnecessary Shocking Sensations

Lawsuit joins a growing number of spinal cord stimulator cases being brought against various medical device manufacturers in recent months, each raising similar claims that design changes were not adequately tested.

An Illinois man says he suffered electric shocks due to problems with his Medtronic spinal cord stimulator (SCS), following adjustments made by company representatives who were not qualified medical personnel.

The complaint (PDF) was filed by Steven Hughes in the U.S. District Court for the Southern District of Illinois on February 23, naming Medtronic Inc. and the U.S. Food and Drug Administration (FDA) as defendants. 

Spinal cord stimulators are devices that are surgically implanted to help treat patients with severe chronic back pain. The implant delivers electrical pulses to the spinal cord, which are meant to intercept and interrupt pain signals before they reach the brain. 

Each device consists of a battery-powered pulse generator implanted under the skin, thin electrical leads positioned along the spinal cord and an external controller that allows doctors or patients to adjust stimulation levels. Once implanted, the device is designed to be left in the patient’s body permanently.

Spinal Cord Stimulator Problems

Spinal cord stimulators were first introduced in the early 2000s, and manufacturers have released multiple updated versions in the years since. Many of those newer models were cleared through the U.S. Food and Drug Administration’s 510(k) process, which allows devices to reach the market if they are deemed “substantially equivalent” to an existing product, without requiring full clinical trials.

However, critics argue that significant design and programming changes have been cleared through that pathway with limited independent safety testing. In recent months, patients have reported sudden electrical jolts, burning sensations, worsening pain and new neurological symptoms, with some requiring revision or removal surgeries after devices allegedly malfunctioned or overstimulated nerves.

As a result, manufacturers are now facing spinal cord stimulator lawsuits filed in courts nationwide, each alleging that inadequately tested design changes increased the risk of malfunction, including lead fracture or migration, electrical overstimulation, unsatisfactory pain relief and other neurological complications.

According to his lawsuit, Hughes suffers from cervical spondylosis with chronic back and neck pain. After traditional approaches failed, he was implanted with a Medtronic SCS as part of a medical trial, which was determined to be successful at the time in March 2018.

The complaint indicates the system consisted of a pair of Medtronic Vectris surgical leads (Model 977A260) and a Medtronic Intellis neurostimulator (Model 97716), with tunneling and implantation of the pulse generator in the lower back.

Following implantation, Hughes reported suffering persistent and worsening pain at the implantation site, leading to pain in his back and legs, and shocking sensations from unintended stimulation events. This led to trouble with sleeping, mobility and the performance of daily activities, he indicates.

“Throughout this period, Plaintiff had multiple interactions with Medtronic sales representatives, who were routinely present at his programming sessions and actively adjusted Plaintiff’s IPG without the supervision or input of licensed medical professionals. Medtronic’s sales representatives acted as technical authorities in the clinical environment, guiding programming decisions and advising on the device’s performance issues.”

– Steven Hughes v. Medtronic Inc. et al

Hughes states that whenever he complained about problems with the device, the Medtronic representatives told him to be patient while they tried to dial the device in, and failed to warn him of issues with the device that they knew existed. 

The lawsuit alleges that Medtronic failed to properly report adverse events and product problems to the U.S. Food and Drug Administration. When reports were submitted, the complaint claims they were incomplete, delayed or minimized the severity of the device’s malfunctions and resulting patient injuries.

Hughes presents claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, unauthorized practice of medicine, and violations of the Illinois Consumer Protection Act and of the Administrative Procedure Act.

SCS Injury Lawsuits

The complaint comes just days after a group of plaintiffs filed a motion to transfer with the U.S. Judicial Panel on Multidistrict Litigation (JPML), calling for the formation of an SCS injury lawsuit MDL, or multidistrict litigation. They requested all federal lawsuits brought against Abbott Laboratories or Boston Scientific be centralized in the Northern District of Illinois for coordinated discovery and pretrial proceedings before one U.S. District Judge.

At least 15 lawsuits have been filed against those two manufacturers in five different federal jurisdictions were currently pending when the motion was filed on February 20. Plaintiffs have not yet requested Medtronic spinal cord stimulator lawsuits to be included in the MDL.

As the number of Abbott, Boston Scientific, Medtronic and other manufacturers continues to grow, spinal cord stimulator lawyers are actively reviewing claims for individuals who suffered injuries such as:

• Lead wire fracture or migration
• Electrical shocks or overstimulation
• Sudden loss of pain relief
• Worsening chronic back or nerve pain
• Revision surgery or device removal
• Permanent nerve damage
• Long-term spinal cord complications

All spinal cord stimulator injury lawsuits are handled 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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