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EnTrust implantable cardiac defibrillators - battery problems
The TGA advises patients and health care professionals of problems with the battery life in some EnTrust ICD D154ATG (ARTG number 119254) and EnTrust ICD D154VRC (ARTG number 119256) implantable cardiac defibrillators (ICDs).
Two problems have been identified with these particular ICDs:
- They may not operate for as long as expected.
- They may not operate for the full timeframe of at least three months between the alert for it to be replaced [the Elective Replacement Indicator (ERI)] and the End of Life (EOL) alert.
These problems are caused by an internal battery short that develops as the battery capacity is consumed.
At the time of writing the TGA has not been advised of any deaths or serious injuries as a result of these problems.
All of these issues occurred at least 30 months (two and a half years) after the device had been implanted.
Less than 1000 EnTrust ICDs have been supplied in Australia (about 39,000 are currently implanted worldwide).
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|EnTrust ICD D154ATG||16|
Information for consumers
If you have an implanted ICD:
- Check the brand and model number of your ICD. This issue only affects EnTrust ICD D154ATG and EnTrust ICD D154VRC.
If your ICD is an Entrust ICD D154ATG or D154VRC:
- Check when your Entrust ICD was implanted. If it was implanted more than 30 months (two and a half years) ago, then make an appointment with your cardiologist as soon as possible. When making the appointment, explain that you are responding to this safety alert.
- Ensure you attend regular follow-up appointments with your cardiologist.
- If your pacemaker starts to make a beeping sound, contact your cardiologist immediately or go to a hospital emergency department.
- There is no reason for the affected defibrillators to be removed until the ERI alert occurs.
Patients with any ICD should carry their identification card with them at all times. If you have any concerns, regardless of the type of defibrillator you have, contact a health professional, preferably the cardiologist who implanted the device.
Information for interventional cardiologists
Medtronic (the manufacturer), has advised that:
- Patients with an affected device that has reached ERI - even if they have been seen recently - should undergo a replacement procedure as soon as possible.
- Replacement of devices should occur promptly if the decline in voltage is more rapid than expected after the ERI has been reached.
- Audible patient alerts for "Low Battery Voltage ERI" and "Excessive Charge Time EOL" should be switched on.
- Routine follow-up sessions at least every three months should continue, in accordance with product labelling.
- Prophylactic replacement of EnTrust ICDs is not recommended.
Information for all health professionals
Patients with an EnTrust ICD D154ATG or EnTrust ICD D154VRC implanted more than 30 months (two and a half years) ago should be referred to a cardiologist, preferably the implanting cardiologist.
The reported events have involved a drop in battery voltage from ~3.0 V to ERI (2.61 V) over a time period ranging from approximately one week to six months.
The manufacturer Medtronic has confirmed ten reports of failure of a component in the electronic circulatory, all occurring between the ERI alert and removal of the device. There have been no reports of loss of high voltage therapy between ERI and device removal.
Consumers and health professionals are encouraged to report problems with medical devices. Please refer to the TGA Internet site for more information on the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give personal advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.