Medtronic said Friday 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, which was provided to The New York Times by lawyers suing Medtronic.

When Medtronic may have known the Sprint Fidelis posed safety problems, and how it responded to that information, could be significant factors if patient lawsuits over the product were to start moving forward again. This month, top Democratic lawmakers introduced legislation that would effectively nullify a Supreme Court decision last year that has blocked lawsuits against medical device makers like Medtronic. The company recently said that about 2,000 legal claims involving the Sprint Fidelis had been filed against it. The death statistics Medtronic released Friday underscore both the scope of the Sprint Fidelis problem and the difficult choices that doctors and patients face in deciding what to do about it. About 150,000 people in this country still have the Sprint Fidelis leads in their bodies.

Read the full article on the New York Times website [off-site link].

Learn more about Medtronic heart lead dangers and victims' legal rights.