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Defib Wire Warning Shouldn't Worry Most Users: Experts
Date:10/15/2007

rmally, that individual should simply be followed," Zipes advised.

Another expert agreed. "This is a very manageable problem," said Dr. Bruce D. Lindsay, president of the Heart Rhythm Society. Unless the lead is fractured, there is no need to have it replaced, he said.

Lindsay said that patients normally have their defibrillator checked every three months. With the newest devices, patients can even have their defibrillator checked from home via phone. "We can look at that information just as if they came to the clinic," he said.

To find out if you have one of these leads, all you have to do is look at the card that your doctor gave to you after the defibrillator was implanted, Zipes said.

Based on their data, Medtronic said the risk to any one patient is very small.

"These fractures happen at a low rate, and most patients will never experience a fracture," said Medtronic spokeswoman Marybeth Thorsgaard. "Thirty-month data suggests a fracture rate of less than 2.5 percent," she said.

Thorsgaard agreed that patients with these leads should talk with their doctors about the problem. "Actions can be taken to program the device that can reduce the risk to patients and improve monitoring by physicians," she said. This includes an audible warning indicating that a lead is broken, she added.

Implantable cardioverter defibrillators and Cardiac Resynchronization Therapy-Defibrillators are used to treat abnormal heart rhythms that can cause the heart to stop. These devices shock the heart back into normal rhythm by sending a pulse of energy through the lead connected to the heart.

Medtronic is not suggesting that everyone with its Sprint Fidelis leads needs to have them replaced. This is also the advice of several professional groups such as the Heart Rhythm Society and the American College of Cardiology.

Dr. Daniel Schultz, director of the U.S. Food and Drug Administration's Center for D
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