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FDA MedWatch: Medtronic voluntarily suspends distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

October 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.

Read the complete MedWatch 2007 Safety Summary including a link to the FDA Statement and Consumer Questions and Answers.

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About Lieff Cabraser

Founded in 1972, Lieff Cabraser Heimann & Bernstein, LLP is an over sixty attorney law firm with offices in San Francisco, New York and Nashville. We represent clients in defective medical device personal injury lawsuits and other cases.

Copyright © 2012 Lieff Cabraser Heimann & Bernstein, LLP        

TRADEMARK NOTICE: "Sprint Fidelis" is a trademark of Medtronic, Inc. Lieff Cabraser is in no way affiliated with Medtronic, Inc. The use of this mark is solely for informational and product identification purposes.

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