Events

Alerta De Seguridad para EP-CARTO Navigation System

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Biosense Webster,Inc || Biosense Webster, Ltd.

¿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
    I1702-48
  • Número del evento
    2007DM-0000863
  • Fecha
    2017-02-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=102
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports on the electrical activity of the heart and the location of the catheter during electrophysiology (ep) procedures, despite the very low probability (0.000086%) that a patient may experience a ventricular arrhythmia due to a leakage, so which have decided to reinforce this important information, regarding the factors that can contribute to the leakage of current described in the instructions for use, reducing the possibility of potentially adverse events occurring on patients.

Device

EP-CARTO Navigation System
  • Modelo / Serial
  • Descripción del producto
    The CARTO-XP system is designed to generate cardiac electrophysiological maps in third dimension through decatéteres and provides substantial information about the electrical activity of the heart.
  • Manufacturer
    Biosense Webster,Inc || Biosense Webster, Ltd

Manufacturer

Biosense Webster,Inc || Biosense Webster, Ltd