Health Canada — Medical Devices · Canada · 2022-07-04 · Type I
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Reported risk: Medtronic is notifying health care professionals of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (hv) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (crt-ds). Through 03-June-2022, Medtronic has identified 27 devices (0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a short circuit protection (scp) alert. Medtronic has not received any reports of permanent harm or death due to this issue. Medtronic is also requesting hospitals quarantine and return a subset of non-implanted Medtronic Cobalt and Crome icds crt-ds. An identified list (i.e. subset) of specific serial numbers may have a manufacturing non-conformance that can contribute to the potential for reduced shock energy during high-voltage therapy. These devices will undergo additional inspection to ensure conformance to manufacturing specifications, once retrieved from the field. Recall start date: June 22, 2022
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