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FDA OKs Medtronic system to find ICD lead cracks

Thu Sep 4, 2008 9:23am EDT

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CHICAGO, Sept 4 (Reuters) - The U.S. Food and Drug Administration on Thursday said it approved a software update from Medtronic Inc (MDT.N) that will help detect fractures of the company's Sprint Fidelis heart defibrillator lead.

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The Sprint Fidelis lead was the subject of an October 2007 Medtronic recall because it was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all.

Most of the patients with the Sprint Fidelis lead still have the device implanted because of the surgical risk associated with removal, and are being monitored by their health care providers for potential fracture, FDA said. (Reporting by Debra Sherman, editing by Gerald E. McCormick)



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