Robert Hauser News
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The insulation coating on St. Jude Medical Inc.’s Durata lead, used to connect a life-saving defibrillator to the heart, can fray when it rubs against another object, according to a study that didn’t raise substantial new concerns about the device.
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The journal HeartRhythm said it stands by a study released last month showing St. Jude Medical Inc.’s recalled Riata wires, used to connect life-saving defibrillators to the heart, may fatally short-circuit.
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St. Jude Medical Inc.’s Riata, a cable used in heart defibrillators, is the latest example of a defective medical device that wasn’t spotted quickly enough because U.S. surveillance systems are lacking, according to an article in the New England Journal of Medicine.
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Recalled St. Jude Medical Inc. wires, still in use to connect life-saving defibrillators to the hearts of 79,000 patients, had multiple defects that led to melted conductors, electrical abnormalities and shocks, a study found.
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St. Jude Medical Inc.’s recalled Riata wires, used to connect life-saving defibrillators to the heart, can short circuit, a defect that may have led to 22 deaths, researchers said.
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Automated systems that comb through hospital databases of information on devices like implanted defibrillators and pacemakers find safety problems years before current approaches identify deadly defects, researchers said.
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