April 2, 2012
Dear Medtronic Patient:
Medtronic recently provided doctors with important information about EnTrust implantable defibrillators (ICD). The EnTrust model numbers affected by this communication are D153DRG, D153VRC, D153ATG, D154VRC, D154DRG and D154ATG. Your patient identification card contains the specific model number you have.
Medtronic has identified a small percentage (less than 0.1%) of EnTrust heart devices in which the battery did not last as long as expected. All implantable devices like yours are batteryoperated, and all battery-operated devices eventually require replacement. These are very sophisticated devices that have been designed to signal when the device is ready to be replaced. Typically, these heart devices have three (3) months of normal operation after the device signals the need for replacement. EnTrust devices may require replacement sooner than expected once the device indicates the need for replacement.
We recommend that you continue your regular device check-ups and appointments as requested by your doctor. Your doctor may program your heart device to give off a beeping sound, at a preset and convenient time of day for you, once your device has indicated the need for replacement. If you hear this beeping or notice a change in how you are feeling, contact your doctor promptly.
You may also contact Medtronic Patient Services to learn more at 800-551-5544 ext. 41835 or via email at email@example.com. Our staff is available to take your call Monday through Friday from 8 a.m. to 5 p.m. Central Time.
We sincerely apologize for any difficulties this may cause you and your family.
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management