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 Infinity DBS System (Model Numbers 6660, 6661, 6662, 6663) [HKMD No.: 210488].
The manufacturer is informing users of a Medical Device Correction regarding the implantable pulse generator (IPG) battery elective replacement indicator (ERI) for patients with non-rechargeable Infinity DBS neurostimulation systems. 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.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Jun 2024