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Medtronic says 13 deaths linked to Sprint Fidelis leads
Saturday, 14 March 2009
Medtronic Inc. says that it has linked a total of thirteen deaths to its Sprint Fidelis lead wires. The company issued a Sprint Fidelis recall in October 2007 over concerns that the lead wires could cause painful, unnecessary shocks to the heart.

In all, Medtronic says that it has received reports of 107 Sprint Fidelis deaths. However, the company has only been able to solidly link 13 of these deaths to the Sprint Fidelis leads. The new figure is the first update of Sprint Fidelis-related fatalities since Medtronic issued the lead wire recall in 2007.

The company was forced to recall the lead wires after learning that they could be at an increased risk of fracturing after being implanted. Fractured lead wires could cause a pacemaker or defibrillator to repeatedly shock the heart, which in some cases could be fatal. About 268,000 Sprint Fidelis lead wires were implanted before reports of side effects force the company to pull the lead wires.