PTN No 81 - Sorin Biomedica - Minidual 50 Pacemaker; Product Code ICV0095

Possible malfunction including premature battery depletion and loss of output.

Sorin Biomedica has advised the Medical Devices Agency (MDA) of the potential for loss of hermeticity among an early population of Minidual 50 pacemakers. The ceramic feedthrough in the pacemaker's header may have suffered cracks caused by a particular tool used in manufacturing, allowing the gradual ingress of body fluids into the pacemaker electronics after implantation. The fluid ingress causes a range of possible failure modes including premature battery depletion, or temporary/permanent loss of pacing, sensing or telemetry.

An accurate assessment of the pacemaker current drain and battery status, using the PMP2000 programmer with dedicated software version 2.1.04, will help to identify pacemakers showing early signs of malfunction.

Only the 292 Minidual 50 pacemakers listed in the Appendix are affected. No other Minidual 50 pacemakers within the UK, and no Minidual 50S pacemakers are affected, as later production was not subject to the same manufacturing process. Sorin Biomedica has provided advice, including the dedicated programmer software and lists of serial numbers of affected pacemakers to the 20 UK centres to which they were distributed. To date, 22 of the 1575 potentially affected Minidual 50 pacemakers worldwide have suffered loss of hermeticity, 6 of which were within the UK.

Clinicians should review all patients implanted with the Minidual 50 pacemakers identified in the Appendix as soon as possible. Consideration should be given to the replacement of pacemakers showing signs of failure and to elective replacement for pacemaker-dependent patients. All other patients should be reassessed at 3-monthly intervals.