Events

Retiro De Equipo (Recall) de VNS Therapy Aspire HC Generator and VNS

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
    59818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0210-2012
  • Fecha de inicio del evento
    2011-08-12
  • Fecha de publicación del evento
    2011-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103797
  • 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
    Stimulator, autonomous nerve, implanted for epilepsy - Product Code LYJ
  • Causa
    The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.
  • Acción
    Cyberonics sent a Field Safety Alert on August 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm decided to recall and initiated contact with implanting facilities in the United States on 08/15/2011. A Field Safety Alert was delivered on 09/19/2011 to implanting facilities. Customers were instructed not to prescribe AspireHC pulse generators for implant until Cyberonics resumes shipment of AspireHC pulse generators that have the issue remedied. Cyberonics recommends that physicians continue their current practice of titrating programming parameters for patients implanted with an AspireHC pulse generator to achieve appropriate clinical outcomes, paying particular attention to report of: Lack or loss of efficacy Pain, inflammation, swelling/edema in the neck area; and/or Patient perception of stimulation or muscle twitching in the area surrounding the implant. Cyberonics recommended routine systems diagnostic testing to aid in device and patient monitoring. Physicians may contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com. For questions regarding this recall call 281-228-7323.

Device

VNS Therapy Aspire HC Generator and VNS
  • Modelo / Serial
    Model 105, VNS Therapy AspireHC Generator
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including TN, TX, IL, OH, FL, CA, CO, OR, AZ, NY, PA, MO, NJ, WI, OK, MI, ID, KY, IA, MA, NE, GA, LA, NY, and Norway.
  • Descripción del producto
    VNS Therapy Aspire HC Generator and VNS, Model 105 || Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058 || For implantation in humans to treat Epilepsy and Depression.
  • 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