Events

Safety Alert for Navigation Game System POLESTAR

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Navigation Israel, Ltd || Medtronic Inc. Cardiac Rhythm Disease.

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
  • Event ID
    I1606-257
  • Event Number
    2010DM-0005479
  • Date
    2016-06-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=135
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer informs that it has detected the possibility that the ground connection is interrupted in these components, which could suppose a potential risk of electric shock for the user if it comes in direct contact with any of them, leading to the possibility of potential adverse events.

Device

Navigation Game System POLESTAR
  • Model / Serial
    506A0107 / 506A0297 / 506A0298 / 506A0187 / 506A0186, specific serials.
  • Product Description
    The MEDTRONIC computer-assisted surgery system and its associated applications were designed to help locate anatomical structures and plan surgical trajectories in open and percutaneous interventions. Its use is indicated for any clinical disorder for which it is considered appropriate to use stereotactic surgery and where it can establish a reference to a rigid anatomical structure in relation to diagnostic images of the anatomy.
  • Manufacturer
    Medtronic Navigation Israel, Ltd || Medtronic Inc. Cardiac Rhythm Disease

Manufacturer

Medtronic Navigation Israel, Ltd || Medtronic Inc. Cardiac Rhythm Disease
  • 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
    NIDFSINVIMA