Events

Retiro De Equipo (Recall) de Device Recall VNS Therapy System Generator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cyberonics, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    47442
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0995-2009
  • Fecha de inicio del evento
    2008-02-07
  • Fecha de publicación del evento
    2009-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69509
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    implantable vagus nerve stimulator - Product Code LYJ
  • Causa
    Reset/disabling of the vns therapy demipulse generator and demipulse duo generator due to magnet interference, resulting in the loss of stimulation.
  • Acción
    Cyberonics notified consignees of recall via letter on 02/07/08. Consignees were notified of reset issue in which during a strong magnetic field, the software may report an error even though no error occurred. This error causes the generator to reset, which disables the generator (i.e., no stimulation delivered). Physicians should inform any potential and currently implanted patients of the possibility of this event. Patients should continue with their regularly scheduled visits as determined by their physician. If this event is suspected, physicians should interrogate the device as described in the Physicians Manual to confirm the generator has been reset and Cyberonics should be contacted for any additional instruction.

Device

Device Recall VNS Therapy System Generator
  • Modelo / Serial
    All lots.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA, Belgium, Germany, Norway, Spain, Sweden, the Netherlands, and United Kingdom.
  • Descripción del producto
    Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator.
  • Manufacturer
    Cyberonics, Inc

Manufacturer

Cyberonics, Inc
  • Dirección del fabricante
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    USFDA