Events

Notificaciones De Seguridad De Campo acerca de Ieoa table and size measuring device for mosaic aortic bioprosthesis of the model 305

Según Agency for Medical Products and Medical Devices of Croatia, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Croatia que fue producido por Medtronic Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2014_medtronic_mosaic_aortic_prosthesis_995
  • Fecha
    2014-01-23
  • País del evento
    Croatia
  • Fuente del evento
    AMPMDC
  • URL de la fuente del evento
    http://www.halmed.hr/en/Medicinski-proizvodi/Sigurnosne-informacije/Sigurnosne-obavijesti-o-medicinskim-proizvodima/2014/Medtronic-Mosaic-Aortic-Prosthesis/995
  • Notas / Alertas
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 Croatia.
  • Notas adicionales en la data
    The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Medtronic Inc. on the change of the iEOA table and size measuring device for Mosaic aortic bioprosthesis of the model 305 due to reports to higher than expected transvalvular gradients occurred after implantation.
    The manufacturer has informed users that older versions of tables and measuring device will not be distributed anymore.
    Here you may view the safety information addressed to users.

Device

Ieoa table and size measuring device for mosaic aortic bioprosthesis of the model 305

Manufacturer

Medtronic Inc.
  • 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
    AMPMDC