Potential device malfunction for a subset of Assurity™ and Endurity™ pacemakers

A Dear Healthcare Professional Letter has been issued by Abbott to inform healthcare professionals of the potential device malfunction for a specific subset of serial numbers of Assurity^™ and Endurity^™ pacemakers. This issue stemmed from a specific manufacturing process which is no longer in use. The reported clinical impact of this malfunction included loss of pacing, reduced battery longevity, devices reverting to back-up mode, and/or loss of telemetry or communication. Based on data reviews, the functionality interruption may occur as soon as within a week from the last transmission date in Merlin.net. Healthcare professionals are advised to quarantine and return any unused affected devices to Abbott. For patients implanted with the affected devices, prophylactic replacement is generally not recommended. Healthcare professionals are advised to monitor patients using Merlin.net when possible, to consider individualized therapy up to and including generator replacement for high-risk patients, and to promptly replace devices that receive an Electronic Performance Indicator (EPI) notification or reach Elective Replacement Indicator (ERI). Please refer to the letter for details. Published: 5 Aug 2022

Dear Healthcare Professional Letters