Medtronic Sprint Fidelis Lead Defect Can Be More Of A Problem For Certain Patients

December 18th, 2007    Posted by: Dr. Cox

People With Hypertrophic Cardiomyopathy And Those With Defibrillator-Pacemaker Dual Unit Implants May Be More In Need Of Lead Wire Replacement After Medtronic Recall

As presented in a December 13, 2007 New York Times (NYT) article, “Patients Wonder Whether to Replace a Wire That Might Fail”, for thousands of people the October 2007 Medtronic recall of its Sprint Fidelis lead wires has created confusion and doubt on various levels about what they can or should do, now:

Their defibrillators are meant to deliver electric shocks to restore normal rhythms if their hearts start beating chaotically. Should they have the potentially faulty wire, or lead, removed — or leave it in place and hope it does not fail?

And if they do have it extracted, how will they pay for it? Medtronic is limiting its contribution to only a replacement lead and $800 toward each procedure, which can cost $12,500 or more. So far insurers are deciding whether to cover the replacement operation on a case-by-case basis, unless the lead has already fractured….

From the December 13 article by NYT reporter Barnaby J. Feder we learn that this confusion and doubt about whether to have their Sprint Fidelis defibrillator lead wires removed (or explanted or extracted) and replaced is more profound for some people than it might be for others.

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