Events

Alerta De Seguridad para Implantable Automatic Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT-D)

Según National Drugs Administration from El Salvador (DNM), este evento ( alerta de seguridad ) involucró a un dispositivo médico en El Salvador 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
    Safety alert
  • Clase de Riesgo del Evento
    Class I
  • Fecha
    2016-10-11
  • País del evento
    El Salvador
  • Fuente del evento
    DNM
  • URL de la fuente del evento
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notas / Alertas
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
  • Notas adicionales en la data
  • Causa
    The cause of the alert is the premature exhaustion of the battery causing that patients do not have the normal waiting time of three months for the replacement of the device, some batteries have been exhausted within 24 hours after the patient receives an alert eri (elective substitution indicator). the distributor's facilities were visited and the import documents for the year 2013-2016 were reviewed, finding 4 teams whose model numbers are in accordance with the health alert. for which follow-up was done, identifying the doctors who performed the implantation procedure so that they could contact the patients, this communication was made by the health professionals and a control was planned for the patients.
  • Acción
    Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

Implantable Automatic Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
  • Modelo / Serial
    Sanitary DNM Registration Number: IM072716042015
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NDAESDNM