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

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. Published: 20 Oct 2021

Dear Healthcare Professional Letters