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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.
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management