Events

Safety Alert for Medtronic Kappa and Sigma Pacemakers

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

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
    2009-05-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20090519.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
    Follow-up action on medtronic kappa and sigma pacemakers the department of health was informed by medtronic international ltd. yesterday (may 18) that the company was following up on some medtronic kappa and sigma pacemakers. according to the company, the concerned pacemakers may fail due to separation of interconnect wires and may cause loss of rate response, premature battery depletion, intermittent or total loss of signals. the affected devices comprised kappa 600/700/900 and sigma 100/200/300. patients are recommended to consult their doctors immediately if they experience fainting or lightheadedness. there is no reported patient injury or death associated with this failure in hong kong so far. the hospital authority and private hospitals have been informed of this follow up action. there are totally 189 patients implanted with the affected devices in hong kong and they will be informed by the hospitals for follow up actions in a few days' time. end/tuesday, may 19, 2009.

Device

Medtronic Kappa and Sigma Pacemakers

Manufacturer

Medtronic International Ltd.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH