Patients Worldwide Get Warning on Defibrillator Part

Oct 16, 10:42 AM

Current Headlines: By Barnaby J. Feder

The largest U.S. maker of implanted heart devices, Medtronic, said 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 said Sunday that it was 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 to 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.

U.S. federal safety regulators, who participated in the announcement on Sunday, 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 Schultz, director of the Center for Devices and Radiological Health at 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 Fideles before a conference call on Monday 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, Robert Clark.

Clark declined to comment on how many unused leads the company expects to take back and destroy. He said Medtronic would attempt to design a similarly narrow lead to replace the current products but had not decided whether to name it Fidelis.

The Fidelis leads can cost several thousand dollars each, but the actual price varies widely depending on which device they are packaged with and how many a customer is using.

Medtronic is recommending that doctors switch back to its older Quattro lead, but doctors will have other options from other companies. The biggest long-term financial impact on Medtronic could come not from doctors using other leads but from the possibility that they could switch to defibrillator systems from other companies.

Medtronic developed Fidelis as part of the race among cardiac device companies to develop ever more compact and flexible products that can be implanted more easily and safely.

Questions about the performance of the new lead began to surface soon after its introduction. In 2006, researchers at Cornell University Medical Center, in a study abstract published in Circulation, a medical journal, questioned whether the lead, the thinnest one made by Medtronic, was durable enough.

Then earlier this year later, Dr. Robert Hauser of the Minneapolis Heart Institute published an analysis that found, among other things, that a significant number of patients were experiencing "inappropriate" shocks because their defibrillator was firing when not needed. Such jolts can be extremely painful.

Hauser, who played a central role several years ago in bringing to light malfunctions in Guidant defibrillators in 2004, said that he had discussed his findings with Medtronic officials, who said there was not enough data to come to any conclusions. In March, however, the company did issue a letter to doctors sharing those concerns with doctors.

Five deaths have been linked to the fractures as a possible, though not confirmed, contributor.

Barry Meier contributed reporting.

Originally published by The New York Times Media Group.

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