Events

Alerte De Sécurité sur Navigation Game System POLESTAR

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Medtronic Navigation Israel, Ltd || Medtronic Inc. Cardiac Rhythm Disease.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1606-257
  • Numéro de l'événement
    2010DM-0005479
  • Date
    2016-06-27
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=135
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    506A0107 / 506A0297 / 506A0298 / 506A0187 / 506A0186, specific serials.
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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