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Defibrillator manufacturer Medtronic Inc. is warning patients and health care providers that an electrical wire (called a "lead") that links the defibrillator to the heart could fracture. Medtronic is voluntarily suspending all distribution of the "Sprint Fidelis" leads. Medtronic defibrillators have included the Fidelis lead since 2004. According to a Press Release from Medtronic, Inc., the estimated 268,000 patients who have been implanted with Sprint Fidelis leads might experience lead fractures as "audible alerts, inappropriate shocks and/or loss of output," and the company has identified five deaths "in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor." At this time, Medtronic is not recommending replacement of the leads, because risks posed by implanting of a different lead are greater than risks presented by fracture of the Sprint Fidelis lead.
The U.S. Food and Drug Administration (FDA) announced that Medtronic's action is "in the best interest of patient safety," and that while it "can be frightening for a patient to learn that a product they rely on so much might have a serious defect, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized."