Events

Rappel de Device Recall VNS(R) Therapy Programmer

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
    78914
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0555-2018
  • Date de mise en oeuvre de l'événement
    2017-12-02
  • Statut de l'événement
    Completed
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160846
  • 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, autonomic nerve, implanted for epilepsy - Product Code LYJ
  • Cause
    Two model 3000 programmers were distributed in error by prior to fda approval of version 1.0.2.2 software.
  • Action
    The units were collected by visit on December 21, 2017 and December 28, 2017 from the physicians. Both programmers have been successfully removed from the customers and no further actions are being proposed. For further questions, please call (281) 228-7260.

Device

Device Recall VNS(R) Therapy Programmer
  • Modèle / numéro de série
    Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of : CO and ND
  • Description du dispositif
    VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 || Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
  • 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