1 December 2005

The Department of Health was informed by Medtronic International Ltd. today (December 1) that the company was following up on some Medtronic Sigma pacemakers.

According to the company, the concerned pacemakers may fail due to separation of interconnect wires and may cause loss of rate response, premature battery depletion, intermittent or total loss of signals.

Models affected included SD203, SD303, SDR203, SDR303, SDR306, SVDD303, SS103, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVVI103.

Patients are recommended to consult their doctors immediately if they experience dizziness or loss of consciousness. There is no reported patient injury or death associated with this failure so far.

The Hospital Authority and private hospitals have been informed of this follow up action. There are totally 103 patients implanted with the affected devices in Hong Kong and they will be informed by the hospitals for follow up actions in a few days' time.