Events

Alerta De Seguridad para Implantable Neurostimulator for Deep Brain Stimulation. Model: 37601. Anvisa Registry n ° 10339190485.

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.; MEDTRONIC PUERTO RICO OPERATIONS CO..

¿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
    1670
  • Fecha
    2015-08-28
  • 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
    According to the company, this field action aims to notify the health professional about the information being added to the Warnings and Adverse Events sections of the instructions for using the Deep Brain Stimulation (DBS) line of the Medtronic. These updates to the instructions for use result from the company's monitoring of reported events, clinical trials, and published literature. Updates of the instructions for use further clarify the potential risks that have been reported about DBS Therapy. In the company's action plan it is planned to update the instructions for use of the product with Anvisa.
  • Causa
    Inclusion of new adverse events in the instructions for use of the product as a result of reports, clinical trials and published literature regarding deep brain stimulation (dbs) therapy.
  • Acción
    Complementing product use instructions.

Device

Implantable Neurostimulator for Deep Brain Stimulation. Model: 37601. Anvisa Registry n ° 1033919...

Manufacturer

MEDTRONIC COMERCIAL LTDA.; MEDTRONIC PUERTO RICO OPERATIONS CO.
  • 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