The regulator issued its most serious of warnings, citing potential for death.
A Medtronic Inc. device used to stimulate the brain to treat Parkinson’s disease and other neurological conditions has a potentially life-threatening flaw that triggered the highest-level warning from U.S. regulators.
The wires on the ends of Medtronic’s deep-brain stimulators can be damaged by a cap designed to protect the delicate electronics while they are being inserted, the Fridley-based company said Thursday in a news release. The wires, known as leads, can be harmed when the connections inside the cap are twisted during surgery or when the cap is removed.
The U.S. Food and Drug Administration classified the issue as a Class I recall, meaning there is a reasonable probability that the defect could cause serious health consequences or death. Medtronic alerted physicians to the problem in February and has changed the manufacturing in an effort to fix the issue. The change is under FDA review.
The wires may need to be replaced for the patient to get proper treatment if there is extensive damage, the company said. The caps aren’t used in all surgeries to implant the deep brain stimulators, and they don’t always cause harm. If the patients receive therapy as expected after the device is implanted, they aren’t likely to be affected by the flaw, the company said.
Deep-brain stimulation uses electrical pulses to treat Parkinson’s, tremors, obsessive-compulsive disorder and painful, involuntary muscle contractions known as dystonia. It is also used outside of the United States for hard-to-treat epilepsy.