The Department of Health (DH) received notification from a medical device manufacturing company about a voluntary recall of a number of devices used for regulating heartbeats, including cardiac pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), and cardioverter defibrillators (ICDs).
The notification from Guidant Hong Kong Limited involved the following products -
It was found that five devices did not function as a result of failure of the capacitor leading to intermittent or permanent loss of output or premature battery depletion. To date, about 49 800 devices have been distributed and approximately 27 200 devices have been implanted worldwide.
There have been two overseas reports of pacemaker patients experiencing syncope. There have been no other reported serious incidents Locally, no reports of adverse incidents have been received by DH.
According to Guidant Hong Kong Limited, i n Hong Kong , 32 devices have been implanted in hospitals under Hospital Authority (HA) and private hospitals. Guidant has contacted HA and related doctors to advise them to follow up 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 Guidant Hong Kong Limited's hotline at 2593 2206 for enquiry.
The DH has informed public and private hospitals, and medical professional associations about this recall action and advise them to take necessary follow up actions. DH welcomes the timely actions taken by Guidant as a responsible manufacturer to issue this recall.