Advisory letter regarding a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Through 10 April 2023, Medtronic has identified 27 devices from approximately 816,000 devices (representing 0.003%) distributed worldwide that have experienced a reduced- or no-energy HV therapy due to the issue described in this letter. There have been no deaths due to this issue in the glassed feedthrough device population.

Letter below.

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• Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy, FDA, Medical Device Recalls, 7/18/2023