A shocking problem: Patients are trying to figure out whether to live with a recalled Medtronic defibrillator lead known as Fidelis, or to undergo lengthy, expensive surgery to have their devices replaced. Meanwhile, experts are debating just how many of these parts--thousands of which have already been implanted into patients--are likely to fail.
The part at issue, of course, is an electrical lead that connects a defibrillator to the patient's heart. When it "fractures," the lead can fail to shock a patient when necessary to correct a misfiring heart, or shock a patient unnecessarily and repeatedly. At a device conference, one expert estimated that half of all leads--not just Medtronic's version--removed from patients might have failed. One study, released in April, estimated that 40 percent fail within eight years. And even the FDA itself is saying that these parts might not be adequately tested before marketing.
Back at the hospital, the defibrillator-replacement procedure can cost $12,500 or more. Medtronic is paying $800 of that, plus contributing a replacement lead. Who pays the rest? Insurance companies say they'll consider it on a case-by-case basis.