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Press Release

Software Defects Cause Malfunctioning in Medtronic's Implantable Cardiac Devices

The Department of Health (DH) today (May 5) received notification from Medtronic International Limited (MIL), the local branch of a multi-national medical device manufacturer, that software problems in six of its implantable cardiac devices may risk life-threatening though rare malfunctioning.

A DH spokesman said, the affected models are Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK) and Maximo II DR/VR (D284DRC, D284VRC). All except Maximo II VR (D284VRC) are distributed in Hong Kong.

As of April 19 this year, the manufacturer has received five confirmed reports of defect out of approximately 144 000 devices sold worldwide. However, it is reassuring that no patient injury or death arising from the affected devices has been reported thus far.

Here in Hong Kong, MIL's record shows that a total of 40 affected devices have been implanted in patients of either Hospital Authority or private hospitals.

MIL recommends no change to current patient management. The devices will receive software updating upon the patients’ next scheduled clinic follow-up. The company is contacting physicians concerned individually.

The spokesman does alert patients who have the deficient implants that if they experience cardiac symptoms or hear alerts from the devices, they should seek medical attention immediately.

Patients can call MIL’s hotline at 2919 6413 for further details.

Meanwhile, the DH has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with MIL on further development, if any.

Ends/Wednesday, May 5, 2010

 
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Last Revision Date : 15 December 2012