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Medtronic warns of defect in its defibrillator

NEW YORK -The nation's largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component because it was prone to a defect that has apparently been linked to five deaths and has malfunctioned in hundreds of patients.

The faulty component is an electrical "lead," or a wire that connects the heart to a defibrillator, a device that shocks faltering hearts back into normal rhythm.

The company is urging all of the roughly 235,000 patients with the lead, known as the Sprint Fidelis, to see their doctors to make sure it has not developed a fracture that can cause the device to 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 most cases, the defibrillators can be reprogrammed without surgery to minimize the likelihood of faulty shocks.

Replacing leads on a heart device like a defibrillator is considered by experts to be far more dangerous than replacing the device itself. As a result, doctors said that patients are better off leaving the lead in place except in those instances where it has ceased to function.

Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or between 4,000 and 5,000 people, will experience a lead fracture within 30 months of implantation. Those patients will need to have the lead replaced, experts said.

The Fidelis lead has been used with Medtronic defibrillators since 2004, and most patients who received Medtronic defibrillators since then have them.

Patients like Vice President Dick Cheney who have recently had defibrillators replaced because their batteries were running down may not have the leads because doctors commonly attach replacement defibrillators to the existing leads when possible.

Federal safety regulators endorsed Medtronic's actions, which included a worldwide halt to sales and a recall of all Fidelis leads not yet implanted.

Medtronic is also sharing its findings with overseas regulators. "Pulling this device from the market is the right thing to do," said Daniel G. Schultz, of the Food and Drug Administration. "This is a model for how these types of events should be handled."

The recall is the latest in a series of setbacks for Medtronic and its two main rivals in the $6 billion global defibrillator market, St. Jude Medical and Boston Scientific. Sales have slumped in the United States in the last two years because of a string of safety recalls and concern among doctors that it is too difficult to identify which patients will benefit from the devices, which can cost $30,000 or more.

Medtronic declined to discuss the potential financial impact of its actions regarding Fidelis prior to a conference call this morning with Wall Street analysts.

Medtronic has more than 55 percent of the defibrillator market, and the devices are its biggest product.

Medtronic will cover the cost of a replacement lead for those that have fractured, and pay as much as $800 in medical expenses that are not covered by insurance. But the company will not pay for procedures to replace functioning leads that patients want taken out to head off potential problems, said a company spokesman.

Medtronic is recommending that doctors switch back to its older Quattro lead, but doctors will have other options from other companies.

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