Events

Alerta De Seguridad para Stealth Station System

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Medtronic Navigation Inc. || Medtronic Inc. Cardiac Rhythm Disease.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    R1707-298
  • Número del evento
    2009DM-0004170
  • Fecha
    2017-07-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=79
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    suction instruments reference AxiEM ENT
  • Descripción del producto
    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
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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