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Serious safety concern regarding some Medico implantable pacemakers

     The Department of Health (DH) today (January 27) warned the public that certain Medico implantable pacemakers run the serious risk of not functioning.

     DH, through its routine surveillance on medical devices, noticed that the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has made an alert on a report by the Italian manufacturer Medico that a group of its implantable cardiac stimulators, Sophos 151, Sophos 155 and Helios 300, might fail to function. Medico discovered this during a routine follow-up and on analysis of Sophos 151 pacemaker serial number MDAA473, found that the malfunctioning was because of intermittent instability of the electrical continuity of some inner substrate connections.  

     A DH spokesman remarked that although the incidence of failure is low, quoted to be 0.013%, and thus far there is no record of these products being marketed in Hong Kong, or reports of adverse reactions received, but the terrible consequence of such a malfunction combined with the possibility that some Hong Kong residents may have obtained one of these pacemakers overseas provide sufficient cause for this warning.

     The serial numbers of the Medico pacemakers involved are -

a)  Sophos 151, serial numbers from MDAA378 to MDAA383, from MDAA385 to MDAA411, from MDAA413 to MDAA421, MDAA423, MDAA424, from MDAA426 to MDAA448, from MDAA450 to MDAA464, from MDAA466 to MDAA472, from MDAA474 to MDAA483, from MDAA496 to MDAA506;

b)  Sophos 155 with serial numbers from MDFA222 to MDFA234, from MDFA236 to MDFA312; and

c)  Helios 300 with serial numbers from MB3A111 to MB3A120.

     While DH will continue to check with Medico and MHRA about any export of these products to Hong Kong and monitor the development of the issue, the spokesman said: "Any member of the public who has been implanted with any of the affected products should consult their healthcare workers for advice as soon as possible."

     Meanwhile, DH has also informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant.

Ends/Thursday, January 27, 2011
Issued at HKT 16:21


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