Events

Safety Alert Or Field Safety Notices for External pacemaker: MICRO-PACE REF 4580

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Pace Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/2012
  • Event Number
    CON222586
  • Date
    2013-01-10
  • Event Date Posted
    2013-01-10
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON222586?tabName=allTabs
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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addressing the potential for loss of ventricular output or sensing failure, pace medical inc has temporarily withdrawn the micro-pace ref 4580 from sale.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 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.
  • Action
    Update to MDA/2012/070 New units:  MICRO-PACE REF 4580 have been withdrawn from sale until further notice.  Units already in use: if insufficient alternative devices are available, continued use should be based upon an individual risk assessment of the patient, taking account of factors such as: degree of pacing dependency arrhythmia history the level of additional patient monitoring; in particular, for loss of ventricular sensing or capture. Units that have not been upgraded (see MDA/2012/070) should not be used with epicardial leads. Report all adverse incidents involving these pacemakers to the MHRA’s Adverse Incident Centre and the manufacturer.

Device

External pacemaker: MICRO-PACE REF 4580
  • Model / Serial
  • Product Description
    External pacemaker: MICRO-PACE REF 4580.
  • Manufacturer
    Pace Medical

Manufacturer

Pace Medical