Events

Alerta De Seguridad para INSYNC®III (CRT-P) Models 8042, 8042B, 8042U

Según Digemid, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Peru que fue producido por Medtronic.

¿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
    ALERTA DIGEMID Nº 66 - 2015
  • Fecha
    2015-12-24
  • País del evento
    Peru
  • Fuente del evento
    Digemid
  • URL de la fuente del evento
    http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Alertas/2015/ALERTA_66-15.pdf
  • Notas / Alertas
    Peruvian data is current through August 2018. All of the data comes from Digemid, 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 Peru.
  • Notas adicionales en la data
  • Causa
    Long-term battery performance.

Device

INSYNC®III (CRT-P) Models 8042, 8042B, 8042U

Manufacturer

Medtronic
  • 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.
  • Representante del fabricante
    -
  • Source
    Digemid