Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its EnTrust VR/DRI AT (ICDs) [Model: D154ATG, D154VRC].
The manufacturer has identified of the potential for loss of high voltage and anti-tachycardia pacing therapy in the affected products as they near elective replacement indicator (ERI) voltage.
According to the manufacturer, under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no 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, leading to a loss of high voltage and anti-tachycardia pacing therapy. Bradycardia therapies will continue to operate as expected.
Through 15 Jun 2018, the manufacturer has confirmed 25 charge timeout events related to the issue, with no patient deaths or complications. Time from implant to the devices experiencing the issue is ranging from 7.9-11.7 years.
The affected users are recommended to take the following actions:
Additionally, the manufacturer recommends the actions to help ensure patient safety and effective high voltage therapy remain as the device battery voltage approaches its 2.61V ERI threshold
The manufacturer will offer a supplemental device warranty for prophylactic replacements as defined under the patient management recommendations.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 June 2018