Events

Alerta De Seguridad para Specify electrode kit, models 39565 and 39286, registration 10339190365, risk class IV, several batches (SEE ANNEX).

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
    1787
  • Fecha
    2015-01-06
  • 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
    Reinforced the need to read the new Instruction of Use. #### UPDATED ON 07/24/2017, the company submitted the field action completion report proving the sending of the safety notice to the customer, change in the instruction of use in the product registration.
  • Causa
    Instructions for use of 5-6-5 and 2x8 specify surgical conductors are not distinguish between intraoperative pacing test with a permanent surgical conductor and use for interoperative test evaluation.
  • Acción
    Change of Instructions for Use. Action Code FA691. The team should be aware that 5-6-5 and 2x8 Specify ™ surgical conductors are not intended for use for interoperative testing (ie, testing / screening outside the operating room with an external neurostimulator).

Device

Specify electrode kit, models 39565 and 39286, registration 10339190365, risk class IV, several b...

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