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

evices and Radiological Health, also offered some reassurance to patients. "We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect," he said in a statement released Monday. "However, patients can be assured that the likelihood of fracture is very low, and FDA is committed to ensuring that the risk to patients is minimized."

Schultz added that his agency will soon be issuing a "recall classification" regarding the Sprint Fidelis leads. This does not mean that the devices must be surgically removed, he said, only that new ones should not be implanted in patients.

"Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead, because removal carries risks," Schultz said. "Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model."

Schultz also noted that "a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic." Patients who are unsure as to whether they are using the Sprint Fidelis lead should consult with their physician, he said.

If the lead is fractured, Medtronic will provided a new lead free of charge. The company has also pledged to pay affected individuals up to $800 in unreimbursed medical expenses, Thorsgaard said.

Zipes described the lead fracture as a relatively minor problem for such a complex device.

"These devices work 99 percent of the time," Zipes said. "Without a device, the patient faces a 100 percent chance of dying, but, with the device, the patient faces a 99 percent chance of living," he said.

Vice President Dick Cheney uses a Medtronic defibrillator, but it was implanted in 2001, before these leads were introduced, The New York Times reported.


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