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Traditional ChineseSimplified ChineseText onlyPDARSS
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October 15, 2007

Notification

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Defibrillation leads distribution suspended
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Department of Health

Medtronic International has voluntarily suspended the worldwide distribution of its four models of implantable defibrillation leads - components of a device to regulate a patient's heartbeat - due to their potential to fracture.

 

The affected products belong to the Sprint Fidelis family of implantable defibrillation leads. The four models are 6930, 6931, 6948 and 6949.

 

According to the company, more than 200 such leads have been distributed to Hong Kong. So far, the Department of Health has not received any report of death or injury in Hong Kong associated with the devices.

 

The department has alerted the Hospital Authority, the private hospitals and the medical professional institutions of the notification and advised them to check with the supplier. It will monitor the development.

 

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

 

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

 

Patients may call the company's hotline, 2907 5911, from 9am to 5.30pm on Monday to Friday for more details.



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