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Medtronic Heart Lead Recall
News Article Excerpt

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December 13, 2007
The New York Times, "Medtronic Patients Wonder Whether to Replace a Wire That Might Fail"
For one heart patient, there will be no more agonizing over whether the implanted device meant to save his life might kill him instead. On Tuesday, two months after Medtronic warned doctors and nearly a quarter-million patients that a wire, or lead, connecting their electronic defibrillators to their hearts might break, the 48-year-old patient had the lead and defibrillator removed and replaced. It required a painstaking 90-minute operation here at Morristown Memorial Hospital. But thousands of other patients with failing hearts remain trapped in doubt. Their defibrillators are meant to deliver electric shocks to restore normal rhythms if their hearts start beating chaotically. Should they have the potentially faulty wire, or lead, removed -- or leave it in place and hope it does not fail?

And if they do have it extracted, how will they pay for it? Medtronic is limiting its contribution to only a replacement lead and $800 toward each procedure, which can cost $12,500 or more. So far insurers are deciding whether to cover the replacement operation on a case-by-case basis, unless the lead has already fractured. The lead, called the Fidelis, is a spaghetti-thin plastic tube enclosing electrical wires and sensors. The risks of the patient’s operation, besides the possibility for infection, included potential perforation of his heart and the veins in his chest.

Read a copy of the full article at New York Times.com [off-site link].

Learn more about Medtronic defibrillator lead lawsuits and the legal rights of patients.
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