Important Safety Alerts

Important Safety Alerts

Heartbeat Regulating Products with Low-voltage Problem

08 Sep 2009

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).

A DH spokesman said, the notification from Medtronic International Limited involved the products, a subset of Concerto CRT-D and a subset of Virtuoso ICD. 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 230 of approximately 6,300 devices overseas have been confirmed to have accelerated battery depletion. According to the company, there have not been any report ed deaths or serious injuries resulting from the problem, both overseas and locally.

According to the Medtronic International Limited, in Hong Kong , three devices have been implanted in hospitals under Hospital Authority (HA). Medtronic has contacted HA and related doctors to advise them how to address the problem .

The spokesman said, individual patients implanted with affected devices should follow their scheduled appointments for follow up. However, they should contact their attending doctors immediately if receive an alert tone coming from their implanted device .

Patients may call Medtronic International Limited's hotline at 2919 6413 for further details about the notification .

The DH has informed public and private hospitals, and medical professional associations about this notification and advise d them to take necessary follow up actions.

Ends/Tuesday, September 8, 2009

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