Medtronic Spinal Cord Stimulator Lawsuit Alleges Device Worsened Pain

Despite having the spinal cord stimulator deactivated, a Kentucky woman still suffers from pain and discomfort related to the Medtronic device being implanted in her body.

A Kentucky woman has filed a product liability lawsuit claiming that a Medtronic spinal cord stimulator caused her to suffer intense burning sensations, erratic shocks and worsened her pain shortly after it was implanted in her body.

The complaint (PDF) was brought by Angela Yates in the U.S. District Court for Minnesota on April 18, naming Medtronic, Inc., Medtronic USA, Inc., and The U.S. Food and Drug Administration (FDA) as defendants.

Spinal cord stimulators (SCS) are implantable neuromodulation devices that send mild electrical pulses to the spinal cord to disrupt pain signals before they reach the brain.

The Medtronic system was originally approved by the FDA in 1984 under Premarket Approval (PMA) No. P840001. Since that time, however, the device has undergone hundreds of design changes and functional upgrades, including new waveforms, rechargeable batteries, firmware updates and MRI compatibility.

According to the lawsuit, these cumulative changes have dramatically altered the device’s safety profile and therapeutic mechanism. Despite this, the FDA never required Medtronic to seek a new PMA or conduct updated clinical trials, allowing substantially modified devices to enter the market under the original 1984 approval.

Yates’ complaint argues that these unvalidated changes introduced previously unknown risks that were not disclosed to her or her physician.

The lawsuit contends that neither Yates nor her doctors could have reasonably understood or anticipated the risks associated with the redesigned spinal stimulators, since Medtronic failed to update its labeling, risk disclosures or training materials. Yates claims the company continued marketing its stimulators as “FDA-approved” despite the fact that the implanted device bore little resemblance to the original design and had never undergone independent evaluation in its current form.

“In many cases, Medtronic introduced entirely new generations of neurostimulators, functionally distinct from the original system, without obtaining a new PMA or undertaking the clinical validation required for first-time approvals,” Yates said.

Due to the numerous design changes over the years, the spinal cord stimulator lawsuit claims that the device implanted in Yates was fundamentally different from products originally approved by the FDA 41 years earlier. Rather than relieving her chronic pain, the modified device allegedly intensified her symptoms, causing burning sensations and unpredictable electric shocks.

As a result of the persistent complications and side effects from her spinal cord stimulator, doctors eventually recommended the device be turned off. However, Yates still experiences pain and discomfort related to it and worries about having it implanted in her body.

Neither Yates nor her doctor were made aware of the many changes and complications that had arisen as a result of Medtronic’s alterations to their SCS device. In fact, the FDA accepted all of Medtronic’s modifications without requiring a reevaluation of any new designs, which Yates alleges was not in accordance with the FDA’s mandate under federal law.

“Medtronic’s conduct deprived physicians of accurate safety information and misled patients into accepting implantation of devices that had never undergone independent evaluation in their current form,” Yates said. “The company’s failure to provide adequate post-market risk management violated both federal regulations and parallel state law duties.”

Yates is raising allegations against Medtronic of manufacturing defect, failure to warn, negligence per se and breach of federal regulatory duties, breach of implied warranty, fraudulent misrepresentation, deceptive trade practices and consumer protection violations, and unauthorized practice of medicine. At the same time, she is raising allegations against the FDA of violation of the Administrative Procedure Act (APA).

She is seeking compensatory, statutory and punitive damages, as well as declaratory and injunctive relief.

Medtronic Recalls Over Medical Device Problems 

Yates’ lawsuit over the spinal cord stimulator is one of several product safety issues Medtronic has faced in recent years. Federal regulators have announced multiple recalls involving Medtronic medical devices, highlighting ongoing concerns about the company’s quality control and post-market risk management.

In March 2024, the FDA announced a Class I recall for Medtronic MiniMed 600 series insulin pumps due to battery cap defects that could lead to unexpected power loss and insulin delivery interruptions, posing a risk of severe hyperglycemia or diabetic ketoacidosis. 

Just two months earlier, in January 2024, a separate Class I recall was issued for the same line of insulin pumps due to air pressure sensitivity, which may result in overdelivery of insulin and dangerously low blood sugar levels.

In addition, Medtronic recalled its Pipeline Flex Embolization Devices in July 2023 after multiple reports of device fractures during procedures to treat brain aneurysms, some of which resulted in serious injury or death. That same month, the company issued a Class I recall for a cardiopulmonary bypass heat exchanger used during open-heart surgeries, after discovering loose particulate matter in the sealed system that could enter a patient’s bloodstream.