MICRO-PACE REF 4580 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.

Update to MDA/2013/001 (55Kb) and MDA/2012/070 (67Kb) on the return to market of the MICRO-PACE REF 4580.In January 2013 the MHRA issued Medical Device Alert MDA/2013/001 advising that Pace Medical had decided to cease further sales of MICRO-PACE REF 4580 external pacemakers in response to safety concerns. The MDA also gave advice on risk management for units already in use.We have since carried out an audit of both Pace Medical’s US manufacturing site and the UK authorised representative’s premises. Following this audit the manufacturer provided satisfactory responses in the areas of post-market surveillance where deficiencies had been found.Although the MHRA has received a small number of adverse incident reports involving this external pacemaker model, since our last MDA in January 2013, the manufacturer has provided sufficient feedback during our investigations to reassure us that these were not related to any new root causes. Nevertheless, clinicians should continue to closely monitor the safe operation of these devices and to report any new incidents to both the MHRA and the manufacturer.In consultation with the MHRA, Pace Medical has now decided to resume sales of MICRO-PACE REF 4580 external pacemakers in the UK and elsewhere. We will continue to scrutinise the safety of these devices and review the appropriateness of this decision in light of any new information arising from further reported incidents, or other sources.In addition, we have asked Pace Medical to remove all affected devices from UK hospitals which still require any one of the three modifications described in MDA/2012/070. The company has already confirmed that they now have enough loan units available to allow this process to take place without service disruption.Pace Medical has also recently confirmed that their products are currently sold with a statement that their expected service life is ten years from the date of purchase, and that they will not service or repair product returned after this time. Although this information was not provided when older devices were sold, they have confirmed that this condition for servicing or repair applies retrospectively to all Pace Medical devices.