Sprint Fidelis Lead Wire | Medtronic Class Action News
The following patient letter from Medtronic follows increasing information that questions the safety of its Sprint Fidelis leads. An estimated 150,000 heart patients in the United States have implanted Sprint Fidelis leads that were subject to the 2007 Medtronic recall. The Medtronic leads can fracture in a certain number of patients leading to unnecessary shocks or failing to deliver a therapeutic shock when needed. At least 13 patient deaths are thought to be linked to the recalled Medtronic lead wires.
Important Patient Information
Sprint Fidelis® Lead Performance
March 13, 2009
Re: Sprint Fidelis® Lead Performance Update (Models 6949, 6948, 6931, 6930)
Open Letter to Sprint Fidelis Lead Patients:
We recently published updated information on Sprint Fidelis leads for your doctor to review. The chance that there will be a problem with your Sprint Fidelis lead remains small. The information we make available to your doctor about Sprint Fidelis lead performance is more detailed, since he or she is in the best position to know how to manage your care in light of your specific health considerations.
As a reminder, a defibrillation system consists of a device implanted near the shoulder and one or more defibrillation leads connecting the device to the heart. This letter pertains to your Sprint Fidelis lead only, not your implanted heart device.
We will continue to actively monitor Sprint Fidelis lead performance and will publish that performance four times per year on Medtronic’s website for your doctor to review.
If you have questions about your Sprint Fidelis lead, please contact your doctor’s office. Medtronic Patient Services is also available to answer your questions. Please contact us at 1-800-551-5544, extension 41835, between 7 am to 6 pm, Central Time.
Sincerely,
Timothy Samsel
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management
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U.S. Food & Drug Administration Statement On Medtronic Sprint Fidelis Defibrillator
Medtronic Suspends Sprint Fidelis Defibrillation Leads (PDF)
U.S. FDA Class 1 Recall Report
If you or a loved one have been injured by the Medtronic Sprint Fidelis lead please contact us immediately. You may be entitled to compensation.
Some people who have been harmed by defective Medtronic leads have filed lawsuits against the manufacturer. But, before filing a Medtronic lead lawsuit, there are several things that you should know.
Which product is defective?
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