Events

Alerta De Seguridad para APPLICATION CARD OF MODEL 8870 SOFTWARE USED IN MEDICAL PROGRAMMER 8840 N VISION. Related Appliances: SYNCHROMED II IMPUTABLE INFUSION PUMP (10339190229); ACTIVE PROGRAMMABLE NEUROSTIMULATOR (10339190338); MEDTRONIC PROGRAMMABLE NEUROSTIMULATOR (10339190310); PROGRAMMER N`VISION MEDTRONIC (10339190180).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medtronic Comercial Ltda..

¿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
    1303
  • Fecha
    2013-10-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    Verify the details of the field action in the Medtronic Field Emergency Notification issued at Med.gov 08/27/2014: Field action completed by the company on 04/30/2014.
  • Causa
    Problems in the model 8870 software application card used in 8840 n'vision ™ medical programmer may lead to the following failures in the above devices: (1) in synchromed ii deployable infusion pumps: erroneous replacement by date and early / premature reservoir alarm ; (2) in programmable neurostimulators: loss of stimulation and excessive stimulation.
  • Acción
    Medtronic is contacting its customers to begin updating the software.

Device

APPLICATION CARD OF MODEL 8870 SOFTWARE USED IN MEDICAL PROGRAMMER 8840 N VISION. Related Applian...

Manufacturer

Medtronic Comercial Ltda.
  • 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
    ANVSANVISA