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Health Sciences Authority
Dear Healthcare Professional Letters

Firmware update for subset of Gallant™ and Entrant™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

Audiences

Healthcare professional

Industry member

Product type

Medical devices

23 August 2023

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

A Dear Healthcare Professional Letter has been issued by Abbott Cardiac Rhythm Management to inform healthcare professionals of a potential for a Bluetooth (BLE) circuit component issue on a subset of Gallant™ and Entrant™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured prior to April 2022. Affected models are CDVRA500Q, CDDRA500Q, CDHFA500Q, CDVRA300Q, CDDRA300Q and CDHFA300Q. This issue has been associated with a risk of loss of Bluetooth communication (and therefore a loss of remote monitoring), higher than normal current consumption, and reduced device longevity. A firmware update pr00.10.87.04 will eliminate the potential for affected devices from entering the high current consumption mode should the BLE circuit component issue occur. Healthcare professionals are advised to check the firmware version of the implanted device in the programmer report and upgrade the firmware version of affected devices by interrogating patients in-clinic with recommended programmer models. Following firmware upgrade, healthcare professionals may continue to follow patients routinely at the recommended interval per the device User’s Manual. 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 (opens in new tab) 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.