Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted the medical device safety alerts concerning Medtronic Inc. Cobalt XT, Cobalt and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) [HKMD No.: 200462].
According to the TGA, the manufacturer 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.
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. The devices will undergo additional inspection to ensure conformance to manufacturing specifications.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00812-1 and https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00811-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Jun 2022