Events

Rappel de Kinetra Implantable Neurostimulator

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 Medtronic Neurological.

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
    35110
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0861-06
  • Date de mise en oeuvre de l'événement
    2006-04-04
  • Date de publication de l'événement
    2006-05-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-12-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45370
  • 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, Electrical, Implanted, For Parkinsonian Tremor - Product Code MHY
  • Cause
    A specific subset of model 7428 kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. this failure mechanism may present clinically as loss of functionality and a return of the patient's underlying medical conditions.
  • Action
    An Urgent Device Recall Important Patient Management Information letter was sent to implanting and following physicians of patients who have received the device. The letter describes the issue and provides recommendations.

Device

Kinetra Implantable Neurostimulator
  • Modèle / numéro de série
    NFD621879S, NFD621891S, NFD621901S, NFD621981S, NFD621976S, NFD622170S, NFD622185S, NFD622189S, NFD622201S, NFD622247S, NFD622279S, NFD623035S, NFD622345S, NFD622349S, NFD622372S, NFD622382S, NFD622387S, NFD622400S, NFD622414S, NFD622466S,  NFD622542S, NFD622564S, NFD622629S, NFD622664S
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    USA--States of CA, OR, PA. Internationally -Belgium, France, Germany, Italy, Spain, Switzerland, United Kingdom
  • Description du dispositif
    Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. Kinetra neurostimulator is a component of the Activa System. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The dual program Model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case.
  • Manufacturer
    Medtronic Neurological

Manufacturer

Medtronic Neurological
  • Adresse du fabricant
    Medtronic Neurological, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA