Events

Retiro De Equipo O Alerta De Seguridad para Implantable cardiac defibrillators (ICDs) and defibrillators with cardiac resynchronization therapy (CRT-Ds) Platinium, models DF4: VR 1240, DR 1540, CRT-D 1741, SonR CRT-D1841, 4LV CRT-D 1744, 4LV SonR CRT-D 1844

Según Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en Spain que fue producido por N/A.

¿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
    Recall / Safety Alert
  • Fecha
    2018-03-22
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Withdrawal from the market of certain models and serial numbers of DAIs and CRT-Ds Platinium models DF4, due to the possibility of intermittent contact loss of the DF4 connectors, which could cause the patient not to receive the necessary therapy. Follow-up of implanted patients according to what is indicated in the instructions for use, one month after discharge, and then every three months until the replacement date approaches. RECOMMENDATIONS The AEMPS, consulted by the Spanish Society of Cardiology (SEC), considers that the general recommendations of the company are adequate for the follow-up of implanted patients, emphasizing the importance of patients being included in the remote monitoring program through of the SMARTVIEW system.

Device

Implantable cardiac defibrillators (ICDs) and defibrillators with cardiac resynchronization thera...
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    AEMPSVFOI