September 23, 2005

The Department of Health has been notified by the Guidant Corporation of an "Important Medical Device Safety information and Corrective Action" concerning their INSIGNIA and NEXUS implantable cardiac pacemakers.

The concerned pacemakers may not function properly without warning and can result in serious health complications, such as syncope which required emergency hospitalization. There have been no reported deaths associated with the malfunction of the affected pacemakers.

The manufacturer has advised doctors in Hospital Authority and private hospitals of this important safety information. There are 115 patients implanted with the affected devices in Hong Kong and they will be informed by their doctors for follow up actions in a few days' time.

The Department of Health has alerted the Hospital Authority, private hospitals and medical associations of this safety information.