Rare potential serious failure mode in a subset of Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ cardiac resynchronization therapy pacemakers due to the development of leakway pathway in the ceramic capacitor

Medtronic International Limited would like to inform healthcare professionals of a rare but potentially serious failure mode in a subset of Azure^™ and Astra^™ pacemakers, and Percepta^™, Serena^™ and Solara^™ cardiac resynchronization therapy pacemakers, manufactured with a specific multilayer ceramic capacitor. The failure mode is due to the internal cracking within these capacitors resulting in the development of leakage pathways, causing high current drain and rapid battery depletion. As the predicted rate of failure due to this issue is low and there has been recent implementation of process and component enhancements, device replacement is not recommended. Healthcare professionals are advised to continue normal patient follow-up in accordance with standard practice, to continue to utilize the low battery voltage wireless CareAlert^™ (shipped ON), together with remote monitoring via CareLink^™ home monitor or the MyCareLink Heart^™ mobile app and to verify the status of the implanted system as well as the clinical effectiveness of the device at each patient follow-up. Please refer to the letter for more details.