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Recall of Sprint Fidelis Cardiac Leads

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Medtronic Inc. has stopped distributing Sprint Fidelis defibrillation leads because of the possibility that these leads could fracture in a small percentage of patients.

Although the leads continue to function properly in the vast majority of patients, if one does fracture, the defibrillator could deliver unnecessary shocks or not operate at all. Some deaths and major complications have occurred when the leads fractured.

The affected products are Sprint Fidelis Models 6930, 6931, 6948, and 6949. They are used with implantable cardioverter-defibrillators (ICD) or cardiac resynchronization therapy defibrillators (CRT-D).

Medtronic is advising physicians to stop implanting the leads and to return unused leads to the company. FDA and Medtronic are not recommending prophylactic removal of the leads in most patients, because the risk of removing the lead exceeds the small risk of a fracture.

In addition, the company recommends reprogramming the device to monitor the patient more effectively for potential problems, and to provide an audible alert if a lead does fracture.

Patients who have the Sprint Fidelis lead should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Patients should also recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients think they have a Sprint Fidelis lead, or if they do not know the model of their lead, they should contact their doctor.

Additional Information:

FDA MedWatch Safety Alert. Medtronic Sprint Fidelis Defibrillator Leads. October 16, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fidelis

Medtronic, Inc. Important Information About the Sprint Fidelis® Defibrillator Lead. October 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/linkwarning/linkwarning.cfm?link=http%3A%2F%2Fwww%2Emedtronic%2Ecom%2Ffidelis%2F

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