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One year after Medtronic recall, few Sprint Fidelis leads have been removed |
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Monday, 20 October 2008 |
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Doctors with the University of Toledo Medical Center state that one year after the Sprint Fidelis recall, only a small portion of defibrillator patients have had the lead wires in their devices replaced. Medtronic issued a recall notice on the Sprint Fidelis lead wires in October 2007 over concerns that they were prone to fracture, increasing the risk of repeated painful and unnecessary shocks to the heart.
According to University of Toledo cardiologists, only five of the 80 patients who received a Sprint Fidelis lead wire have had them replaced. Another nearby facility, St. Vincent Mercy Medical Center, states that it has removed only four out of the 500 lead wires that doctors there had implanted.
Medtronic says that at least five deaths in the U.S. have been linked to problems with the Sprint Fidelis defibrillator leads. One patient treated at the University of Toledo received about 20 unnecessary shocks to the heart from a defibrillator that used a Sprint Fidelis lead, doctors there say.
Because of the risks associated with removing the defibrillator lead wires, doctors only chose to remove the device in cases where defects may lead to injuries. However, the University of Toledo says that it monitors patients with a Sprint Fidelis lead more frequently in order to be alert for possible problems. |