13 Deaths Tied to Medtronic Heart Device

Despite reports circulating as early as 2004 about problems with the Sprint Fidelis cable, Medtronic's medical device is still in widespread use. Barry Meier of the New York Times reports that along with roughly 13 fatalities, the FDA has received reports of 2,200 reports of serious injuries. Here's an excerpt of the article:

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.

A top Medtronic official said in an interview on Friday that the manufacturing change in question was unrelated to the reasons for the recall and that even at the time of the recall internal data did not suggest it was fracturing at a significantly higher rate than other company leads.

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.

ECB