The Department of Health received notification from a medical device manufacturing company about a software problem in two programming devices used by doctors for checking the battery level of pacemakers.
The programming devices concerned, produced by St. Jude Medical Inc., are APS III Model 3500/3510 programming devices (software versions 6.1.1 and earlier) and Merlin PCS Model 3650 programming devices (software versions 4.1.1 and earlier). They are specially designed and made to measure the battery level of the following three pacemaker models manufactured by the same company -
A spokesman for DH said the software problem may lead to incorrect reporting of battery voltage, expected battery lifespan of the pacemakers and early replacement indicator in the devices. The details can be found at the corporate website of St. Jude Medical, Inc. at www.sjm.com.
DH has alerted the Hospital Authority, private hospitals and other relevant medical professional organisations of this safety information.
No patient injury or death has been reported so far.
The spokesman said patients shall call the hotlines of St. Jude Medical ( Hong Kong ) Ltd at 2996 7688 from 9 am to 6 pm from Monday to Friday for enquiries. They can call 9666 4545 or 9777 0097 outside office hours.
He reminded patients with these implanted pacemakers to attend scheduled regular check-ups arranged with their doctors. If they have any symptoms of heart disease, they should seek medical attention immediately.
End/Thursday, October 19, 2006
NNNN