Events

Safety Alert for Sigma® Pacemakers

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

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
    2005-12-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20051201.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 sigma® pacemakers 1 december 2005 the department of health was informed by medtronic international ltd. today (december 1) that the company was following up on some medtronic 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. models affected included sd203, sd303, sdr203, sdr303, sdr306, svdd303, ss103, ss106, ss203, ss303, ssr203, ssr303, ssr306, svvi103. patients are recommended to consult their doctors immediately if they experience dizziness or loss of consciousness. there is no reported patient injury or death associated with this failure so far. the hospital authority and private hospitals have been informed of this follow up action. there are totally 103 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.

Device

Sigma® Pacemakers
  • Model / Serial
  • Product Description
    Press release: Follow-up Action on Medtronic Sigma® Pacemakers
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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