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U.S. Department of Health and Human Services

Safety

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Medtronic Sprint Fidelis Defibrillator Leads

Audience: Cardiologists, emergency services personnel, risk managers, consumers

[UPDATED 10/17/2007] FDA issued a Class I Recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. Patients who are implanted with this lead, or do not know the model of their lead, should contact their physicians for further information.

[Posted 10/16/2007] FDA issued a statement announcing Medtronic's decision to voluntarily suspend distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company.

When a defibrillator lead is slightly more prone to fracture, most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. Patients who are implanted with this lead are encouraged to contact their physicians for further information.

[October 17, 2007 - Recall Notice - FDA]
[October 15, 2007 - FDA Statement - FDA]
[October 15, 2007 - Consumer Q&As - FDA]