Medtronic SCS Lawsuit Alleges Intellis LT Neurostimulator Caused Worsening Pain

The Medtronic Intellis spinal cord stimulator (SCS) contains numerous manufacturing defects, according the lawsuit, which claims the neurostimulator is prone to cause painful complications.

An Illinois woman has filed a personal injury lawsuit alleging that a defective Medtronic Intellis neurostimulator left her with worsening pain and additional complications after the spinal cord stimulator (SCS) was implanted in her body.

The complaint (PDF) was brought by Lori Lynn Geest in the U.S. District Court for the Northern District of Illinois on March 25, naming Medtronic Inc. and the U.S. Food and Drug Administration (FDA) as defendants.

Spinal cord stimulator (SCS) systems, like the Medtronic Intellis neurostimulator, are designed to deliver electrical impulses to the nervous system to disrupt pain signals before they reach the brain. They are commonly used to treat chronic back, leg and nerve pain when other treatments fail to provide relief.

These devices usually consist 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 SCS system becomes a permanent part of the patient’s body.

Despite their advertised benefits, a growing number of spinal cord stimulator lawsuits have been filed in recent months, with many claims focusing on unapproved or inadequately tested design changes that may have made the devices more prone to malfunctions. Plaintiffs allege these modifications have been linked to issues such as lead breakage or migration, unintended electrical shocks, loss of therapeutic benefit and other neurological complications.

Medtronic Intellis Neurostimulator Allegations

According to the complaint, Geest underwent implantation of a Medtronic Intellis LT neurostimulator (Model 97716) in an effort to manage chronic pain. However, she alleges that the device failed to perform as intended and instead led to worsening pain, discomfort and reduced mobility.

The filing indicates the Intellis neurostimulator delivered inconsistent or ineffective stimulation, which not only failed to alleviate symptoms but allegedly intensified the underlying condition. As a result, the Medtronic SCS lawsuit claims Geest suffered ongoing physical pain, emotional distress and a diminished quality of life.

The complaint further alleges that the manufacturer failed to adequately warn patients and healthcare providers about the potential risks associated with the Medtronic Intellis neurostimulator, including the possibility of ineffective treatment, device malfunction and worsening symptoms following implantation.

In addition, the lawsuit raises concerns about the design, manufacturing and testing of the device, indicating it may not have been sufficiently evaluated for long-term safety and effectiveness before being introduced to the market.

As a result of the alleged complications, Geest says that she may require additional medical treatment, including revision surgery or removal of the device, and continues to experience ongoing symptoms linked to the implant.

“Plaintiff’s injuries resulted from the implantation and use of the adulterated device and the Defendants’ wrongful actions. Any claim that Plaintiff ‘should have known’ about the regulatory violations at the time of injury ignores the fact that this information was hidden by Medtronic and is exclusively found within Medtronic’s and FDA’s regulatory records.”

— Lori Lynn Geest v. Medtronic Inc. et al

The Medtronic SCS lawsuit raises allegations of strict products liability, manufacturing defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, and fraudulent concealment against Medtronic, in addition to claims of violation of the Administrative Procedures Act (APA) against the FDA.

Geest seeks compensatory, statutory, punitive and exemplary damages against Medtronic. She is also asking the court to find that the FDA improperly allowed the Medtronic Intellis neurostimulator to be marketed without full review, strip the manufacturer of federal preemption protections, and block similar approvals in the future.

Spinal Cord Stimulator Lawsuits

The case adds to a growing number of SCS lawsuits being brought nationwide against numerous device manufacturers, including Medtronic, Abbott Laboratories and Boston Scientific. Many of these claims raise similar allegations that spinal cord stimulation devices may fail to provide effective pain relief or cause new complications after implantation.

Last month, a group of plaintiffs who have brought similar SCS lawsuits against Abbott and Boston Scientific filed a petition to consolidate all nationwide federal claims against those defendants before one judge as part of a multidistrict litigation (MDL) in the Northern District of Illinois.

It is unclear how Medtronic SCS lawsuits will affect the plaintiffs’ motion for consolidation, or the U.S. Judicial Panel on Multidistrict Litigation’s (JPML) decision on whether to consolidate them.

If consolidation is granted, it is also uncertain whether other manufacturers’ claims will be included alongside those involving Abbott and Boston Scientific.

Spinal cord stimulator lawyers are currently investigating lawsuits on behalf of individuals implanted with a Medtronic Intellis neurostimulator or similar device who have experienced any of the following complications:

• Electrical shocks or burning sensations linked to stimulation or device wiring
• Device migration or lead movement after implantation
• Tissue burns or localized injury near leads or the generator
• Neurological symptoms associated with lead position or electrical output
• Revision surgery or planned explant surgery due to device complications

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