Events

Safety Alert for Stealth Station System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Navigation Inc. || 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
    R1707-298
  • Event Number
    2009DM-0004170
  • Date
    2017-07-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=79
  • 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 has identified that the referenced devices can not successfully pass the instrument verification stage, this step is performed through the software before the use of each instrument for the purpose of verification and confirmation before use, leading to the possible occurrence delays in the procedures.

Device

Stealth Station System
  • Model / Serial
    suction instruments reference AxiEM ENT
  • Product Description
    The MEDTRONIC computer-assisted surgery system and its associated applications were conceived to help localize 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 employ stereotactic surgery and where a reference to a rigid anatomical structure can be established in relation to diagnostic images of laanatomy.
  • Manufacturer
    Medtronic Navigation Inc. || Medtronic Inc. Cardiac Rhythm Disease

Manufacturer

Medtronic Navigation Inc. || 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