Starting from 1 January 2022, safety alerts related to medical devices listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning multiple models of Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) [Model: Cobal XT/Cobal/Crome ICDs and CRT-Ds; a subset of Claria MRI/Amplia MRI/Compia MRI/Viva/Brava CRT-Ds; and a subset of Visia AF/Visia AF MRI/Evera/Evera MRI/Primo MRI/Mirro MRI ICDs] [HKMD No.: 140340, 140410, 140411, 190111, 200462, 220397].
According to the manufacturer, it was identified a rare potential for reduced- or no-energy output during high voltage (HV) therapy in ICDs and CRT-Ds manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Potential harms related to reduced- or no-energy HV therapy include failure to terminate an arrhythmia, which could lead to death, 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. There have been no deaths due to this issue in the glassed feedthrough device population.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 May 2023