Events

Safety Alert for Sophos 151, Sophos 155 and Helios 300 implantable pacemakers

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medico.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-01-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20110127.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Press release
  • Reason
    Serious safety concern on some medico implantable pacemakersthe department of health (dh) today (january 27) warned the public that a group of implantable pacemakers run the serious risk that they may not function. dh, through its routine surveillance on medical devices, noticed that 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 neither record of marketing or report of field event in hong kong, the dreaded consequence and that there may be occasional patients here who have somehow obtained the devices overseas are what cause the publication of this statement.? 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 the export of the incriminated products to hong kong besides monitoring the development of the issue, the spokesman said: "any member of the public who have 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.

Device

Sophos 151, Sophos 155 and Helios 300 implantable pacemakers
  • Model / Serial
  • Product Description
    Press release: Serious safety concern on some Medico implantable pacemakers
  • Manufacturer
    Medico

Manufacturer

Medico