May 9, 2008
Re: Sprint Fidelis® Lead Performance Update (Models 6949, 6948, 6931, 6930)
Open Letter to Sprint Fidelis Lead Patients:
We recently provided doctors with an update to our October 2007 communication about Sprint Fidelis leads. We told them the chance there will be a problem with your Sprint Fidelis lead remains small, and our recommendations to your doctor remain unchanged.
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. The information we provided to your doctor applies to your Sprint Fidelis lead only, not your implanted heart device.
The information we provided your doctor 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. If you have questions about your Sprint Fidelis lead, please contact your doctor’s office.
If you have additional questions, please contact Medtronic Patient Services at 1(800) 551-5544.
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management
1(800) 551-5544 x41835