Almost 100,000 pacemakers recalled by Medtronic

Medtronic has identified a problem related to long-term battery performance in its InSync III pacemakers and issued a recall

The recall of 96,000 Medtronic pacemakers occurred after the company confirmed that 30 devices worldwide had been impacted by a battery issue.

12 of the 30 devices had reports of unexpected loss of pacing capture with the other 18 devices experiencing some form of erratic behaviour, according to a letter issued by the company.

This erratic behaviour included early elective replacement indication (ERI), significant fluctuations in remaining longevity estimates and inaccurate lead impedances.

Medtronic has also received one report of a patient death where, it is possible but unconfirmed, a pacemaker issue was a contributing factor.

The recall has been given class II status by the US Food and Drug Association (FDA) and Medtronic has said that if pacing capture is compromised, some patients may experience a return of heart failure symptoms due to loss of biventricular pacing.

In cases involving pacemaker-dependent patients a loss of pacing capture could result in serious injury or death according to Medtronic.