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Health Sciences Authority
Dear Healthcare Professional Letters

Potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust ICDs

Audiences

Healthcare professional

Product type

Medical devices

12 July 2018

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Medtronic International Limited would like to inform healthcare professionals of 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. Under certain circumstances, the EnTrust ICD 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, leading to a loss of high voltage and anti-tachycardia pacing therapy. Bradycardia therapies will continue to operate as expected. The rate of occurrence in actively implanted devices is estimated to be 0.00098 in single chamber ICDs and 0.00005 in dual chamber devices. Through June 15, 2018, Medtronic has confirmed 25 charge timeout events related to this issue, with no patient deaths or complications. Healthcare professionals are advised to consider scheduling follow-ups for implanted patients as soon as possible to assess the potential for this issue per steps described, and follow the recommended actions to ensure patient safety and effective high voltage therapy as the device battery voltage approaches ERI threshold. Please refer to the letter for details.


Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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