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Health Sciences Authority
Dear Healthcare Professional Letters

Battery performance alert and cybersecurity firmware updates for certain ICD & CRT-D devices from Abbott

Audiences

Healthcare professional

Product type

Medical devices

27 June 2018

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

St Jude Medical would like to inform healthcare professionals of a planned series of firmware upgrades for specific ICD & CRT-D Devices. These include a battery performance alert (BPA) update to provide further detection capability for premature battery depletion and a cybersecurity update to provide an additional layer of protection against unauthorized device access. The BPA update is for Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, and Unify Quadra™ devices manufactured between January 2010 and May 2015 with risk of premature battery depletion and which are subject to the Medical Device Advisory issued in October 2016. The cybersecurity update caters to Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™.The firmware update process will be via Merlin™ programmer as instructed in the letter. Potential risks with the firmware upgrade include discomfort due to back-up VVI pacing settings, device remaining in back-up mode due to unsuccessful upgrade, and loss of currently programmed device settings or diagnostic data.  Healthcare professionals are advised on the firmware update process and to perform the firmware upgrade for all eligible patients when appropriate. 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.