Medtronic Recall: 10/15/07 Medtronic Dear Patient Letter on Sprint Fidelis Recall

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Oct. 15, 2007 "Dear Patient"
Letter from Medtronic, Inc.

Important Patient Information
Sprint Fidelis® Lead Performance

October 15, 2007

Dear Medtronic Heart Device Patient:

Medtronic recently provided doctors with important information about our Sprint Fidelis defibrillation leads (Models 6930, 6931, 6948, 6949). We have informed doctors who, according to our records, manage the care of patients with Sprint Fidelis leads. A defibrillator system consists of a device implanted near the shoulder and one or more leads connecting the device to the heart. This information applies to Sprint Fidelis leads only, not implanted defibrillation or pacemaker devices. If you have a Sprint Fidelis lead, your Patient ID card should contain one of the following 4 sets of numbers: 6930, 6931, 6948, 6949. These numbers may be shown at the beginning of a longer set of numbers on your ID card.

We have found that there is a small chance of fractures in particular locations on the Sprint Fidelis lead. If you have a Sprint Fidelis lead, the chance there is a problem with your lead is small. Patients with a Sprint Fidelis lead are more likely to experience complications from removal than from a problem with a Sprint Fidelis lead. However, doctors may choose to change the way a 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.

If you have a Sprint Fidelis lead, you may have already heard from your doctor’s office regarding this matter. We encourage patients with Sprint Fidelis leads to contact their doctor’s office with any questions about their leads or the information in this letter. The information we provided doctors is more detailed, since they are in the best position to know how to manage patient care in light of 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 or would like to inquire if you have a Sprint Fidelis lead, please contact Medtronic Patient Services at 1 (800) 551-5544 x41835 (7am to 9pm CST).

Sincerely,

Reggie Groves
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management

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