Ernest Lau, a cardiologist at the Royal Victoria Hospital in Belfast, Ireland, was one of the first doctors to identify a defect in St. Jude Medical Inc.’s Riata that led to its recall in 2011. Now Lau is telling colleagues it’s time to embrace the company’s updated device.
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.
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.
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.
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.
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.