A woman filed a lawsuit against Abbott alleging her Eterna spinal cord stimulator was improperly programmed and led to worsened pain, AboutLawsuits reported May 13.
The lawsuit names Abbott Laboratories, the device manufacturer, and the FDA, which approved the device, and states that the patient had Eterna implanted in December 2023 for chronic pain. She had a trial implant before a sales representative claimed a permanent implant would be as effective or more so.
After initial pain relief, the woman alleged severe complications including shocks and extremity numbness, her lawsuit said. According to the lawsuit, a sales representative without medical licenses made adjustments to the device’s programming, but the adjustments failed to improve her pain.
The lawsuit seeks compensatory and punitive damages.
“We stand behind the safety, quality and performance of our spinal cord stimulation systems. These technologies help manage chronic pain and provide meaningful relief, improving patients’ overall quality of life,” a spokesperson for Abbott said in a May 15 email to Becker’s. “They are highly regulated medical devices that have been approved and updated in accordance with federal law through the FDA’s rigorous premarket approval and supplement processes. We strongly disagree with the allegations in this lawsuit and believe they are without merit.”
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