Events

Safety Alert for CareLink 2090 Programmer

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
    2013-10-07
  • Event Date Posted
    2013-10-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131007a.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
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic carelink 2090 programmer the therapeutic goods administration (tga), australia issued a medical device safety alert concerning carelink 2090 programmer manufactured by medtronic. the affected serial numbers are pkk010877r and pkk054660r. medtronic has identified that a small subset of 2090 programmers have an incorrect software configuration for the country in which that are physically located. when a programmer is manufactured, it is configured for the region in which it will be located. in this way, medtronic is able to differentiate the timing of software updates across different regions of the globe. through the investigation of this issue, a small subset of programmers have been determined to be physically located in a country outside of the region for which they are configured. medtronic is requesting users to return affected devices for re-configuration. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01024-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 7 october 2013.

Device

CareLink 2090 Programmer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic CareLink 2090 Programmer
  • 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