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 Aveir VR Leadless Pacemakers [Model number: LSP112V; Firmware version: 19.05.00] [HKMD No.: 230179].
The manufacturer is informing customers of the potential for electromagnetic interference to cause an inadvertent mode change in a subset of Aveir VR LSP112V devices manufactured with firmware version 19.05.00.
There have been zero (0) reports of permanent harm to patients due to this issue with two devices replaced due to early detection of Recommended Replacement Time (RRT). If present, the mode change is detected during a Merlin programmer interrogation session as the Aveir VR device may potentially present in Emergency VVI (EVVI) or MRI (VOO) mode. As communication with the implanted Aveir VR pacemaker requires a Merlin programmer (remote monitoring is not currently available), the issue will be detected at a scheduled in-clinic follow-up unless patient symptoms prompt an earlier evaluation.
The issue may cause an Aveir VR device to enter either EVVI or MRI mode. The parameters for EVVI mode are VVI pacing at 6 V @ 0.6 ms and 70 bpm, and MRI mode is VOO mode at 5 V @ 1 ms and 85 bpm. Compared to nominal settings, the increased pacing output and rate of each mode may reduce longevity.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 08 Apr 2024