Updates on potential device malfunction in a subset of Assurity™ and Endurity™ pacemakers

A Dear Healthcare Professional Letter has been issued by Abbott, as a follow-up to their earlier communication in August 2022, to update healthcare professionals of supplemental information on the risk timing of potential device malfunction for a specific subset of Assurity^™ and Endurity^™ pacemakers. This is for their consideration to determine the appropriate course of action for patients. The issue stemmed from an intermittent manufacturing laser surface preparation subprocess at the device header joint potentially leading to moisture ingress. The average observed time to functionality interruption continues to be 2.2 years post implant. In addition, there is a high degree of statistical confidence (95%) that, if a malfunction were to occur, 99% of devices will present functionality interruption at or after 1.44 years (526 days). There are no changes to the patient management recommendations communicated previously. Healthcare professionals are advised to always monitor patients and use their own medical judgement to make medical decisions, considering each patient's individual clinical situation. 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.