The nation’s largest maker of implanted heart devices, Medtronic, said yesterday that it was voluntarily urging doctors to stop using a family of leads known as the Sprint Fidelis, a crucial component in its most recent implantable defibrillator models, because the leads break too often.
Medtronic told doctors to stop using the Sprint Fidelis wires after linking five deaths to breaks in them. The company said the Fidelis wires failed slightly more often than the thicker wires they were meant to replace. A lead is a wire that connects the heart to a defibrillator, a device implanted near the shoulder that shocks faltering hearts back into normal rhythm.
An estimated 235,000 patients are thought to have Fidelis leads, and the company estimates that 4,000 to 5,000 patients – or about 2.3 percent – will experience fractures in the leads that can make the device misread heart-rhythm data. Such a malfunction can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life-saving one to a patient in need.
In 2005, Medtronic recalled some of its implantable defibrillators because their batteries were draining without warning. Subsequently Guidant began the first of a series of major recalls.
Over the last two years, since the disclosure of safety problems with heart defibrillators made by another producer, Guidant, device makers and regulators have paid closer attention to tracking defibrillators after they reach the market.
Doctors say the risks involved with removing the lead is much higher than leaving it in. Removing it, they say, could lead to excess bleeding, infection, a perforation of the heart and even death because after being implanted, a defibrillator starts to “cement” to the heart with the formation of scar tissue. Medtronic did not recommend removing leads already implanted in patients.
Instead of replacing the wire, doctors said it may be less risky to install a new device or new wire and leave the old one in.
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