Inhomogeneous epoxy mixing resulting in device malfunction in a subset of Abbott Assurity™ And Endurity™ pacemakers

A Dear Healthcare Professional Letter has been issued by Abbott Medical (Singapore) to inform healthcare professionals of the potential device malfunction for a subset of Assurity^TM and Endurity^TM pacemakers (Models PM1152, PM1162, PM1172, PM1272, PM2152, PM2162, PM2172 and PM2272). This issue stemmed from incomplete mixing of epoxy during manufacturing which may permit moisture ingress into the pulse generator header, thereby interrupting device functionality. The specific manufacturing equipment associated with this issue is no longer in use and no affected devices remain available for implant. Prophylactic generator replacement is not recommended due to the low rate of occurrence of this issue and there have not been any reports of permanent harm to patients. Healthcare professionals are advised to monitor patients with routine follow-up as per standard of care, with prompt replacement of devices that demonstrate unexpected depletion to Electronic Performance Indicator (EPI), trigger an EPI notification, or demonstrate clinical impact. 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.