Low malfunction rate detected among a subset of Assurity™ and Endurity™ pacemakers due to manufacturing process

A Dear Healthcare Professional Letter has been issued by Abbott to inform healthcare professionals of a low rate (0.049%) of malfunctions detected among a subset of Assurity^™ and Endurity^™ pacemakers manufactured on specific manufacturing equipment between 2015 and 2018, due to intermittent incomplete mixing of epoxy during manufacture, allowing moisture ingress into the pulse generator header. These affected units were from a manufacturing process which is no longer in use and no affected devices remain available for implant. The reported clinical impact 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). No cases of serious harm to patients have been reported to Abbott. 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 reach ERI or EOS unexpectedly or experience one of the clinical impacts listed above. 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 when prompt replacement is performed following an unexpected ERI/EOS alert. Please refer to the letter for details. Published: 24 Mar 2021

Dear Healthcare Professional Letters