Safety Advisory Regarding Medtronic EnTrust ICDs

6/27/2018

Safety Advisory Regarding Medtronic EnTrust ICDs

On June 21, Medtronic announced a medical device recall affecting a small percentage (less than 0.1%) of EnTrust heart devices in which the battery did not last as long as expected. 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.

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 says:

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 pshelp@medtronic.com. Our staff is available to take your call Monday through Friday from 8 a.m. to 5 p.m. Central Time.

Please read more here and here.

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Warning Signs
- Family history of unexpected, unexplained sudden death under age 40.
- Fainting or seizure during exercise, excitement or startle.
- Consistent or unusual chest pain &/or shortness of breath during exercise.

Safety Advisory Regarding Medtronic EnTrust ICDs

Online Community

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Warning Signs