Skip to main content
A Singapore Government Agency Website How to identify
Official website links end with .gov.sg
Secure websites use HTTPS
Look for a lock () or https:// as an added precaution. Share sensitive information only on official, secure websites.
Government officials will never ask you to transfer money or disclose bank log-in details over a phone call.

Call the 24/7 ScamShield Helpline at 1799 if you are unsure if something is a scam.

Health Sciences Authority
Dear Healthcare Professional Letters

Expanded range of Assurity™ and Endurity™ pacemakers with low malfun​ction rate due to manufacturing process

Audiences

Healthcare professional

Industry member

Product type

Medical devices

20 October 2021

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, as a follow-up to the earlier communication issued on 24 March 2021, to update healthcare professionals that the range of Assurity™ and Endurity™ pacemakers exhibiting moisture ingress due to intermittent incomplete mixing of epoxy during manufacture has been expanded to include approximately 240,000 additional devices with an issue rate of 0.01%. Reported clinical impact has included loss of telemetry/communication, reduced battery longevity, loss of pacing, and/or shortened duration between Elective Replacement Indicator (ERI) and End of Service (EOS). Abbott has deployed a new Electronics Performance Indicator (EPI) tool to assist in patient management in patients followed with Merlin.net. The EPI tool supplements the ERI and EOS indicators using data available on Merlin.net to identify abnormal electrical system behavior resulting from loss of hermeticity, on average 6 weeks before an interruption of a device function. Healthcare professionals are advised to continue routine follow-up with their patients as per standard of care and clinical protocol and to replace devices that receive an EPI notification, reach ERI/EOS or experience one of the above listed clinical impacts. When possible, healthcare professionals are advised to monitor their patients using Merlin.net to benefit from alert monitoring between routine device checks. Prophylactic generator replacement is not recommended due to the very low occurrence and low potential for patient harm upon prompt replacement following an unexpected ERI/EOS alert. 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.