Medtronic: Heart Device May Have Caused 13 Deaths

Medtronic has claimed in a letter to doctors that 13 people may have died because of a glitch with its heart device wires that first disclosed in 2007.

The Minneapolis, Minn.-based medical device manufacturer pulled its Sprint Fidelis defibrillator leads off the market in October 2007 after discovering that five patient deaths that may have been caused by cracked wires. About 150,000 Americans still have the Sprint Fidelis leads in their bodies.

The company also changed its manufacturing process shortly before removing Spring Fidelis from the market, according to an FDA report.

The company said four of the deaths occurred when physicians tried extracting the wires. Medtronic recommends that patients keep the devices implanted because the risk of surgery could outweigh the risk of a wire malfunction.