The Department of Health (DH) today (October 15) received a notification from a medical device manufacturing company concerning its decision to voluntarily suspend the worldwide distribution of four models of implantable defibrillation leads (components of a device to regulate a patient's heartbeat) due to the potential for lead fractures.

The notification from Medtronic International Ltd involved the Sprint Fidelis family of implantable defibrillation leads. The four models are 6930, 6931, 6948 and 6949.

According to the company, over 200 such leads have been distributed to Hong Kong . So far, DH has not received any report of death or injury in Hong Kong associated with the devices. DH will closely monitor the development.

DH has alerted the Hospital Authority, the private hospitals and the medical professional institutions of the notification and advised them to check with the supplier.

According to the company, lead fractures may present as audible alerts, inappropriate shocks and/or loss of output. Individual patients who think they may have been implanted with the devices in question should contact their attending doctors.

Doctors are advised to immediately stop implanting the devices and contact the company for more information on how to follow-up with patients who have implanted with the leads concerned.

The manufacturer did not recommend immediate replacement of the leads in all patients except in very unusual circumstances.

Patients may call the Medtronic International Ltd's hotline at 2907 5911 from 9:00 am to 5:30 pm on Monday to Friday for details about the notification.

Ends/Monday, October 15, 2007