Events

Rappel de VNS Therapy Aspire HC Generator and VNS

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Cyberonics, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    59818
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0210-2012
  • Date de mise en oeuvre de l'événement
    2011-08-12
  • Date de publication de l'événement
    2011-11-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103797
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Stimulator, autonomous nerve, implanted for epilepsy - Product Code LYJ
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Model 105, VNS Therapy AspireHC Generator
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    USFDA