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.
Medical device manufacturer, Abbott Medical, has issued a medical device safety alert concerning its Proclaim, Proclaim XR, and Proclaim Elite SCS System, Proclaim Plus SCS System and Proclaim DRG Neurostimulation System [Model numbers: 3660, 3661, 3662, 3663, 3665, 3667, 3670, 3671, 3672, 3673, 3664] [HKMD No.: 230053].
According to the manufacturer, the duration between the IPG reaching ERI threshold and end of service (EOS) may be 45-55% shorter than indicated in the product labeling. EOS refers to IPG battery reaching end of life. The shorter duration is due to IPG reaching ERI threshold later than expected; it does not involve premature IPG battery depletion and estimates of overall battery life are not impacted. This could result in loss of therapy if the device reaches EOS prior to replacement surgery.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Jun 2024