Events

Rappel de Cyberonics VNS Therapy System

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
    45958
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0568-2008
  • Date de mise en oeuvre de l'événement
    2007-10-25
  • Date de publication de l'événement
    2008-01-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-10-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66579
  • 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
    Autonomic Nerve Stimulator - Product Code LYJ
  • Cause
    Screen freezes-- the dell x5 handheld pc screen will freeze caused due to incompatibility between the microsoft 2002 os and the model dell x5 handheld computer. once frozen, the handheld device becomes non-responsive to user input.
  • Action
    Cyberonics sent an initial notification (Important Safety Alert) to physicians via Certified Mail on 10/01/07. Letter notified physicians that the Dell X5 handheld computer screen will freeze following an interrogation. Once frozen the handheld device becomes non-responsive to user inputs. The firm informed the user that in the event that the computer becomes non-responsive, the user has two options, 1) Reinitialized the flash memory and, 2) Perform a software reset of the handheld computer. A second notification addressing the approval and addition of labeling was sent to physicians on 11/15/07. Physicians were asked to respond to both letters via an enclosed response card, acknowledging receipt of the notification. Additional information will be posted at www.VNStherapy.com.

Device

Cyberonics VNS Therapy System
  • Modèle / numéro de série
    All Model 250 units using Dell x5 handheld computers.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution- USA and the countries of; Austria, Belgium, Denmark, France, Germany, Ile de la Reunion, Ireland, Israel, Italy, Japan, Marocco, Mexico, Netherlands, Ireland, Norway, Poland, Portugal, S. Korea, Slovenia, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
  • Description du dispositif
    Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher; manufactured by Cyberonics, Inc., Houston, TX.
  • 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