External pacemaker: MICRO-PACE REF 4580 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2013/2012

CON222586

2013-01-10

2013-01-10

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON222586?tabName=allTabs

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addressing the potential for loss of ventricular output or sensing failure, pace medical inc has temporarily withdrawn the micro-pace ref 4580 from sale.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.

Update to MDA/2012/070 New units:  MICRO-PACE REF 4580 have been withdrawn from sale until further notice.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.