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
  • Clase de dispositivo
  • ¿Implante?
  • 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
  • 1 Event


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