Important Safety Alerts

Important Safety Alerts

Follow-up Action on Medtronic Kappa and Sigma Pacemakers

19 May 2009

The Department of Health was informed by Medtronic International Ltd. yesterday (May 18) that the company was following up on some Medtronic Kappa and 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.

The affected devices comprised Kappa 600/700/900 and Sigma 100/200/300.

Patients are recommended to consult their doctors immediately if they experience fainting or lightheadedness. There is no reported patient injury or death associated with this failure in Hong Kong so far.

The Hospital Authority and private hospitals have been informed of this follow up action. There are totally 189 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.

End/Tuesday, May 19, 2009

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