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Health Sciences Authority
Dear Healthcare Professional Letters

Potential device malfunction for a subset of Assurity™ and Endurity™ pacemakers

Audiences

Healthcare professional

Industry member

Product type

Medical devices

5 August 2022

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 to inform healthcare professionals of the potential device malfunction for a specific subset of serial numbers of Assurity™ and Endurity™ pacemakers. This issue stemmed from a specific manufacturing process which is no longer in use. The reported clinical impact of this malfunction included loss of pacing, reduced battery longevity, devices reverting to back-up mode, and/or loss of telemetry or communication. Based on data reviews, the functionality interruption may occur as soon as within a week from the last transmission date in Merlin.net. Healthcare professionals are advised to quarantine and return any unused affected devices to Abbott. For patients implanted with the affected devices, prophylactic replacement is generally not recommended. Healthcare professionals are advised to monitor patients using Merlin.net when possible, to consider individualized therapy up to and including generator replacement for high-risk patients, and to promptly replace devices that receive an Electronic Performance Indicator (EPI) notification or reach Elective Replacement Indicator (ERI). 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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