Important Patient Information on
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
