19 July 2005

The Department of Health has been notified by the Guidant Corporation of an “Urgent Medical Device Safety Information and Corrective Action” concerning some of their implanted cardiac pacemakers.

The pacemakers in question may experience premature battery depletion without warning, inappropriate pacing and early display of replacement indicators.

The affected pacemakers are PULSAR MAX, PULSAR, DISCOVERY, MERIDIAN , PULSAR MAX II, DISCOVERY II, VIRTUS PLUS II, INTELIS II and CONTAK TR pacemakers manufactured between 25 November, 1997 and 26 October, 2000.

If these devices exhibit the above failure mode, patients may notice prolonged rapid heart beating and develop dizziness. In serious circumstances, though uncommon, they may develop heart failure symptoms such as shortness of breath and loss of consciousness.

The manufacturer has sent letters to doctors with patients implanted with the pacemakers to alert them of the incident, and advise replacement of the pacemakers where necessary.

Affected patients are urged to contact their doctors for advice.

Guidant Hong Kong Limited has set up two hot lines 2593 2210 and 6292 2308 for public enquiry during office hours.

The Department of Health has alerted the Hospital Authority, private hospitals and medical associations of the corrective action undertaken by Guidant on some of their cardiac pacemakers.