Medtronic said that at least 13 people might have died in connection with a heart device that it recalled in 2007 but was still in widespread use, including four patients whose deaths were related to efforts by doctors to surgically remove the product.
The new data reflect the first fatality update by Medtronic since October 2007, when it recalled the device — a thin electrical cable that connects an implanted defibrillator to a patient’s heart. The company cited five deaths when it recalled the product, saying fractures in the cable could cause a defibrillator to fail to deliver a lifesaving shock to an erratically beating heart, or to fire for no reason.
Separately, a previously undisclosed Food and Drug Administration report indicates that Medtronic began receiving reports soon after the device reached the market in late 2004 that the cable, known as the Sprint Fidelis, was fracturing. The company also revised its manufacturing process in the months before withdrawing the Sprint Fidelis from the market, according to the F.D.A. report.