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Important Patient Information
Sprint Fidelis Lead Performance
October 22, 2007
Dear Medtronic Heart Device Patient:
Medtronic recently provided doctors with important information about your Sprint Fidelis defibrillation lead (Models 6930, 6931, 6948, 6949). We have informed the doctor who, according to our records, manages your care. A defibrillator system consists of a device implanted near the shoulder and one or more leads connecting the device to your heart. This information applies to your Sprint Fidelis lead only, not your implanted defibrillation device.
We have found that there is a small chance of fractures in particular locations on the Sprint Fidelis lead. The chance there is a problem with your lead is small. You are more likely to experience complications from removal than from a problem with your Sprint Fidelis lead. However, your doctor may choose to change the way your device is programmed to help reduce any potential problems. An independent panel of physician experts recommends against removing Sprint Fidelis leads except in very unusual circumstances.
You may have already heard from your doctor's office regarding this matter. If not, we encourage you to contact your doctor's office with any questions about your leads or the information in this letter. 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.
We sincerely apologize for any difficulties this may cause you and your family. We are committed to answering your questions, keeping you informed, and continuously improving our products. If you have additional questions, please contact Medtronic Patient Services at 1 (800) 551-5544 x41835 or visit www.medtronic.com/fidelis.
Sincerely.
Reggie Groves
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management Medtronic, Inc.
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