(Hong Kong) 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.I called Medtronic technical support and they confirmed the issue. It appears they are not recommending any additional action on the part of patients be undertaken at this time since the problem is only caused if a rare sequence of events takes place. They are awaiting for FDA approval of a software fix for the problem can be upload during patients' next routine device follow-up to avoid the issue.
More details as they become available...
Addendum 7 May 2010 17:27PM: The Dear Doctor letter from Medtronic, posted today.