The Medtronic Sprint Fidelis heart lead recall has impacted over patients worldwide that were implanted with the medical device, a thin electrical cable that connects an implanted defibrillator to a patient’s heart. About 260,000 Sprint Fidelis leads have been implanted in patients in the United States, with 143,000 still active.

When Medtronic introduced the Sprint Fidelis heart lead to the market in 2004, the company hailed it as next generation technology, a lead thinner and easier to implant than its older Sprint Quattro models. However, by  2007, Medtronic stopped selling the lead after reports the wire broke apart inside the body.

Many patients have received repetitive and devastating electrical shocks after their Sprint Fidelis lead fractured. In March 2009, Medtronic disclosed that at least 13 Sprint Fidelis patients may have died, including four patients whose deaths were related to efforts by doctors to surgically remove the product.

A key question from the beginning of the recall has been what is the failure rate of the device.  As noted in a December 29, 2009, Bloomberg article, “A report by UBS Investment Research Monday said lead failures could accelerate over time, citing independent studies that predict failure rates could hit 30 percent by four years.”

For answers to more questions about the Medtronic heart lead recall visit http://www.medtronicheartleadrecall.com. Learn also why it is necessary for Congress to adopt  the Medical Device Safety Act to restore the right of Americans with heart defibrillators, artificial valves, artificial knee and hip implants, and other medical devices to hold manufacturers of faulty products accountable.