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.
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.
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.
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.
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.