The Department of Health (DH) received notification from a medical device manufacturing company about possible battery life-related problem of certain devices used for regulating heartbeats, including Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds).
The notification from Boston Scientific Hong Kong Limited involved the following products –
It was found that the problem is due to a low-voltage capacitor which may be subject to degradation, causing accelerated depletion of the batteries in the affected products.
So far 19 of approximately 73,000 devices overseas have been confirmed to have accelerated battery depletion. According to the company, there have not been any reported deaths or serious injuries resulting from the problem, both overseas and locally.
According to the Boston Scientific Hong Kong Limited, in Hong Kong , 15 devices have been implanted in hospitals under Hospital Authority (HA) and three in private hospitals. Boston Scientific has contacted HA and related doctors to advise them to follow up with patients in their clinics as soon as possible.
Individual patients implanted with affected devices should contact their attending doctors immediately if they have symptoms. Patients may call Boston Scientific Hong Kong Limited's hotline at 2960 7128 or visit Boston Scientific's website at http://www.guidant.com/ppr/advis/2007_04_05.shtml for further details about the notification.
The DH has informed public and private hospitals, and medical professional associations about this notification and advised them to take necessary follow up actions.
Ends
Friday, April 13, 2007