Events

Alerta De Seguridad para Deep brain stimulation electrode kits: (1) Model 3387, (2) Model 3389. all lot numbers

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

¿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
    330
  • Fecha
    2001-11-09
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Some electrodes in the above stimulation kits are not attached to a connector. the manufacturer commenced removal by letter dated january 16, 2001.
  • Acción
    Check receipt of the letter dated January 16, 2001 from Medtronic. Identify and isolate all affected products in your inventory. The manufacturer states that all products that were not implanted were recovered and that all physicians who implanted the stimulators were notified. ECRI recommends that you determine if any of the above units have been deployed in your institution and by whom. Enter the name of the doctor who implanted the product that was removed. The implantologist must decide whether a medical intervention is necessary in patients who have already undergone the implant. Medtronic does not recommend withdrawal of an already implanted product. She states that the error can be controlled and does not recommend implant removal or re-intervention. For more information, contact your local representative or directly with Medtronic at 1 (612) 514-5000 in the United States. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send by fax 0xx61-4481257

Device

Deep brain stimulation electrode kits: (1) Model 3387, (2) Model 3389. all lot numbers

Manufacturer

Medtronic Inc
  • Source
    ANVSANVISA