Medtronic Deep Brain Stimulator Cited by FDA for Flaws
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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 Minneapolis-based company said today in a statement. The wires, known as leads, can be harmed when the connections inside the cap are twisted during surgery or when the cap is removed.