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 a medical device safety alert concerning St. Jude Medical Cardiac Rhythm Management Division The Gallant, Entrant, and Neutrino NxT HV devices [Model numbers: CDVRA500Q, CDDRA500Q, CDHFA500Q, CDVRA600Q, CDDRA600Q, CDHFA600Q, CDVRA300Q, CDDRA300Q, and CDHFA300Q] [HKMD No.: 220022].
According to the TGA, the manufacturer is informing users of a rare potential for a Bluetooth (BLE) circuit component issue on a subset of Gallant, Neutrino, and Entrant Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) manufactured prior to April 2022. This issue has been associated with a risk of loss of Bluetooth communication (and therefore a loss of remote monitoring), higher than normal current consumption, and reduced device longevity.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00734-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Aug 2023