Abbott Spinal Cord Stimulator Lead Problems Caused Burning, Shocks, Lawsuit Alleges

Once removed, doctors discovered that the Abbott spinal cord stimulator system’s electrode leads had migrated out of position and ceased functioning.

A Georgia woman has filed a product liability lawsuit alleging that a defective lead in her Abbott spinal cord stimulator (SCS) malfunctioned, causing painful complications that required additional surgery to remove the implant.

The complaint (PDF) was brought by Kristi Thompson in the U.S. District Court for the Northern District of Illinois on October 12, naming Abbott Laboratories as the sole defendant.

Thompson claims that Abbott sales representatives promised the SCS system would alleviate chronic pain. Instead, it caused more pain, permanent injuries and the need for additional surgeries. She says the manufacturer knew, or should have known, about the failure risks yet did not provide warnings to the medical community or patients.

Spinal Cord Stimulator Problems

Spinal cord stimulators are designed to use electrical pulses to disrupt pain signals on the way to the brain. They consist of a battery-powered pulse generator, electrode leads and the wires connecting them, which are implanted under the skin near the spine, as well as an external remote control to adjust the electrical pulses.

In recent months, numerous reports have linked SCS systems to sudden device failures, painful electrical shocks, leads migrating out of position or protruding through the skin, burning sensations, worsening pain and nerve damage.

Some individuals also report that problems were made worse by company sales representatives, who are not licensed medical professionals but are often responsible for programming and adjusting the implants. These representatives may change stimulation settings in an attempt to improve pain relief, sometimes allegedly without adequate physician oversight, raising concerns that improper adjustments can cause additional complications.

As a result, a number of Abbott SCS implant lawsuits have been filed, as well as similar claims against other manufacturers, including Boston Scientific, Nevro and Medtronic. All of the complaints indicate the companies’ implants were defectively designed and often operated by unlicensed representatives conducting medical procedures.

Spinal Cord Stimulator Lead Problem Allegations

According to the complaint, Thompson received an Abbott Proclaim XR 7 SCS system in February 2018 after undergoing a trial period with a temporary device. Once the device was implanted, Abbott sales representatives, who are not licensed to conduct medical procedures, made adjustments to the system “without meaningful physician supervision.”

“This occurred on numerous occasions after Plaintiff was implanted with the SCS system. Abbott representatives maintained some communication with Plaintiff regarding the implanted SCS system and had at some point informed her of a lead failure.”

– Kristi Thompson v. Abbott Laboratories Inc.

Immediately after the procedure, Thompson indicates she experienced tenderness at the battery site, the remote control failed to respond, and she began feeling pain throughout her lower extremities. The lawsuit states she also experienced sudden electrical shocks and burning sensations, as well as an increase in the pain the device was supposed to prevent.

Ultimately, Thompson had the SCS system removed after discovering the leads had failed. Following the revision surgery, doctors discovered the leads had migrated out of position and were nonfunctional. Thompson claims she still suffers pain and symptoms caused by the failed Abbot implant.

On September 11, 2023, several months after Thompson’s procedure, the U.S. Food and Drug Administration declared that Abbott had issued five Proclaim SCS implant recalls it considered to be Class I, meaning they carried a risk of severe injury or death. The recalls were triggered by reports of plaintiffs suffering:

• Severe electrical shocks
• Sudden unintended stimulation
• Loss of therapy
• Device failure during recharging
• Malfunctioning wireless communication and programming failures.

Thompson presents claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, unauthorized practice of medicine and violation of the Georgia Unfair Business Practices Act and the Illinois Consumer Protection Acts. She seeks both compensatory and punitive damages.

Spinal Cord Stimulator Lawsuits

The complaint comes days after the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all Abbott spinal cord stimulator lawsuits consolidated in the Northern District of Illinois as part of a multidistrict litigation (MDL) before U.S. District Judge Lindsay C. Jenkins, who will now see the litigation through coordinated discovery and pretrial proceedings.

At the same time, the JPML also ordered the consolidation of Nevro spinal cord stimulator lawsuits in the Northern District of California. All Boston Scientific SCS implant lawsuits were previously consolidated in the Central District of California, where U.S. District Judge Josephine L. Staton is expected to begin preparing representative cases for bellwether trials.

Meanwhile, spinal cord stimulator lawyers continue to review claims of injuries caused by implant system problems, including:

Individuals who believe they may qualify for a spinal cord stimulator lawsuit can request a free case evaluation. Attorneys handling these claims work on a contingency fee basis, meaning there are no upfront costs and fees are only collected if compensation is recovered.

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