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Medtronic Releases Data Linking Recalled Sprint Fidelis Lead to 13 Patient Deaths
Data released from Medtronic to doctors on March 13, 2009, in the form of a “Dear Doctor” letter indicates that at least 13 people may have died from a defective heart defibrillator cable that connects the device to a patient’s heart. Reports indicate that lead wire fractures may cause a defibrillator to fail to deliver a lifesaving shock to an erratically beating heart or fire for no reason. About 150,000 people in the United States have been implanted with the Medtronic Sprint Fidelis leads, and patients and their physicians face difficult choices in deciding whether to undergo risky surgery to remove the defective lead wires.
Click here to view "Dear Doctor" letter issued by Medtronic