Increased potential for reduced energy or no energy delivered during HV Therapy in specific Medtronic ICDs and CRT-Ds when programmed with the AX>B pathway

A Dear Healthcare Professional Letter has been issued by Medtronic International, Ltd. to inform healthcare professionals of the rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a glassed feedthrough. When devices in the glassed feedthrough population are programmed exclusively in the B>AX configuration, the potential for a reduced- or no-energy HV therapy is comparable to historical device performance. Potential harms related to reduced- or no-energy output during HV therapy include failure to terminate an arrhythmia, as well as complications associated with device replacement and/or unnecessary lead replacement if the reduced- or no-energy HV therapy is erroneously attributed to a lead failure. Prophylactic device replacement is not recommended.  Healthcare professionals are advised to program all HV therapy pathways to B>AX in all therapy zones, prioritise reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B, and to follow up with their patients implanted with affected devices according to the patient management recommendations provided in the letter. Please refer to the letter for details. Published: 25 May 2023

Dear Healthcare Professional Letters