| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00833-1 |
| Product Name/Description |
EnTrust VR/DR/AT ICDs
Models: D154ATG and D154VRC
ARTG Numbers: 119254; 119256 (both cancelled) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified the potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage.
Affected devices may display an immediate “end of life” (EOL) observation with no prior alert (implanted electronic heart devices are designed to alert physicians and patients as the device battery depletes). Though no elective replacement indicator (ERI) alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation. Bradycardia (pacing) therapies will continue to operate as expected. Medtronic has received no reports of patient deaths or serious adverse events due to this issue. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is advising the below for surgeons following consultation with the Independent Physician Quality Panel:
- Schedule an in-office patient follow-up as soon as possible to assess the potential for this issue per the steps outlined in the Customer Letter.
- Ensure the Excessive Charge Time EOL…and the Low Battery Voltage ERI… Patient Alerts have been programmed to “On-High”.
- Instruct patients to contact your office if they hear device alert tones. Consider utilising the “Demonstrate Tones. . .” function to ensure patients recognise the audible tone.
- If this issue has occurred, an “EOL: replace device immediately” Observation will be displayed on the QuickLook report. Schedule device replacement immediately.
The Customer Letter provides information for surgeons to ensure high voltage therapy remains as the device battery voltage approaches its 2.61V ERI threshold.
This action has been closed out on 27/02/2019 |
| Contact Information |
0466 762 200 - Emma Hassett |