The Department of Health has 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 resynchronisation therapy pacemakers (CRT-Ps), and cardioverter defibrillators (ICDs).
The notification from Guidant Hong Kong Limited involved the following products:
- INSIGNIA pacemakers,
- NEXUS pacemakers,
- CONTAK RENEWAL TR CRT-Ps,
- CONTAK RENEWAL TR 2 CRT-Ps,
- VENTAK PRIZM 2, ICDs,
- VITALITY ICDs, and
- VITALITY 2 ICDs.
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 about 27,200 devices have been implanted worldwide.
There have been two overseas reports of pacemaker patients experiencing syncope (a temporary loss of consciousness). No other serious incidents have been reported. Locally, no reports of adverse incidents have been received by the department.
According to Guidant Hong Kong Limited, in Hong Kong, 32 devices have been implanted in hospitals under the Hospital Authority and private hospitals. Guidant has contacted the Hospital Authority 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 doctors immediately if they have symptoms. Patients may call Guidant Hong Kong Limited's hotline at 2593 2206 for enquiries.
The department has informed public and private hospitals, and medical professional associations about this recall action and advised them to take necessary follow-up action. The department welcomes the timely action taken by Guidant as a responsible manufacturer to issue this recall.
Reprinted from HKSAR Government web page:
http://www.info.gov.hk/gia/general/200606/27/P200606270214.htm