Events

Retiro De Equipo (Recall) de Device Recall VNS Therapy Demipulse Generator and VNS Therapy Demipulse Duo 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
    54020
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0642-2010
  • Fecha de inicio del evento
    2009-11-20
  • Fecha de publicación del evento
    2010-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87244
  • 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
    Autonomic Nerve Stimulator Implanted For Epilepsy - Product Code LYJ
  • Causa
    Under certain conditions, product's battery life can be reduced.
  • Acción
    Firm sent "An Important Safety Notice" letter to all physicians explaining events, risks presented and recommended actions. Letter was mailed November 20, 2009. Physicians should complete and return the effectiveness card as soon as possible to acknowledge that you have read and understood the Safety Alert Letter. If further information is needed, customers in the US can contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com.

Device

Device Recall VNS Therapy Demipulse Generator and VNS Therapy Demipulse Duo Generator
  • Modelo / Serial
    Model 103: Manufactured from 1/25/2007 - present; Model 104: Manufactured from 1/25/2007 - present.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, Argentina, Austria, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Iceland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Panama, Portugal, Republic of Germany, Saudi Arabia, Sweden, Slovakia, Spain, Switzerland, Taiwan, UAE, United Kingdom, and Venezuela.
  • Descripción del producto
    VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. || The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change stimulation settings The Demipulse Generator is an implantable multiprogrammable, device that delivers electrical signals to the vagus nerve. Electrical signals are delivered from the Demipulse Generator to the vagus nerve by the lead. The lead and the Pulse Generator make up the implantable portion of the VNS Therapy System. The external programming system includes the Programming Wand, the programming software, and a compatible computer. The programming software is used with the Programming Wand to allow a physician to read and change the Demipulse Generator settings transcutaneously. || Indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures.
  • 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