Events

Alerta De Seguridad para Navigation Game System POLESTAR

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 Israel, Ltd || 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
    I1606-257
  • Número del evento
    2010DM-0005479
  • Fecha
    2016-06-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=135
  • 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 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
  • Modelo / Serial
    506A0107 / 506A0297 / 506A0298 / 506A0187 / 506A0186, specific serials.
  • Descripción del producto
    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
  • 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