External pacemaker 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

Further to MDA/2012/070 addressing the potential for loss of ventricular output or sensing failure, Pace Medical Inc has temporarily withdrawn the MICRO-PACE REF 4580 from sale.Subsequent to the publication of MDA/2012/070 (67Kb) on 9 October 2012 detailing three manufacturer Field Safety Corrective Actions (FSCAs), the MHRA has received a further incident report of loss of ventricular output due to a soldering failure in a fully upgraded MICRO-PACE REF 4580 pacemaker. After discussion with the MHRA, Pace Medical Inc has decided to remove the MICRO-PACE REF 4580 device from the market. They have confirmed that no further units will be sold until the MHRA has undertaken a review of manufacturing processes, and obtained sufficient evidence to support the safety of this external pacemaker. Specifically, the MHRA will be seeking reassurance that appropriate systems and controls are in place during both the manufacturing and post-production phases to ensure that consistent and safe products are produced.MICRO-PACE REF 4580 pacemakers currently in use are not being recalled, as this could place patients at risk through lack of pacing provision, if alternative devices are not available. Instead, any risks associated with the continued use of these devices should be managed on an individual basis, with particular attention to the need for additional patient monitoring.The MHRA will issue further advice on completion of this investigation.