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Medtronic Links Device for Heart to 13 Deaths

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.

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 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.

Along with fatalities, the F.D.A. has received about 2,200 reports of serious injuries related to the leads. Medtronic officials said they believed that reflected the number of people who had undergone surgery to have a failed lead replaced with a new one.

Dr. David Steinhaus, Medtronic’s medical director, said the updated figures, which the company distributed to doctors, was based on a review of available data by company officials and a panel of five outside physicians.

He said that the outside panel was particularly concerned with the four deaths related to surgical efforts to remove the lead.

Doctors often choose to leave a fractured heart device lead in place when implanting a new one. In the advisory to physicians on Friday, the panel urged that doctors who think a patient would benefit from having a failed lead extracted have the procedure performed by a physician skilled in doing so.

Besides the deaths related to the surgeries, the panel appears to have concluded that the nine other deaths may have been tied to the device’s failure to function properly.

The report shows that by late 2005 the company had received 30 complaints about device fractures and had identified several possible ways in which the lead might be failing. About that time, the company opened an internal investigation into the problem, according to the report.

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