In April 2012, Pace Medical issued a Field Safety Notice due to a risk of inadequate output from the MicroPace 4580 model pacemakers. As is often the case MHRA has seen fit to issue its own Medical Device Alert on the subject, which can be found in full here.
Pace Medical believes the problem with its device arises from damage caused by application of direct heart defibrillation when the pacemaker is used with epicardial pacing wires. As such it has put in place actions aimed at solving the output problem by replacing an electronic component in devices in the field.
At the end of June 2012, the manufacturer issued a second Field Safety Notice due to reports of under-sensing, once again when the pacemaker was used with epicardial pacing wires following surgery. A further schedule of field up-grades began for all 4,580 pacemakers in use.
In September 2012, the manufacturer issued a third Field Safety Notice to implement a further hardware upgrade to these temporary pacemakers, introducing a component to provide greater protection in the event of defibrillation. This action arose from their continued investigations, which had improved their understanding of the root cause of the failures.
To date there have been no reported problems when these pacemakers have been used with temporary endocardial pacing leads.
What to do
According to the MHRA alert, these pacemakers should not be used with epicardial pacing wires until they have undergone all three upgrades notified in the manufacturer’s Field Safety Notices of April, June and September 2012. Pacemakers should be returned to the manufacturer to be upgraded and loan units requested if required to ensure continued availability of devices. All adverse incidents involving these pacemakers should be reported to the MHRA’s Adverse Incident Centre and the manufacturer.