Events

Rappel de Device Recall Medtronic 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
    35967
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0290-2007
  • Date de mise en oeuvre de l'événement
    2006-07-19
  • Date de publication de l'événement
    2006-12-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-04-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47276
  • 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
    neurostimulator - Product Code MHY
  • Cause
    A subset of kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.
  • Action
    Letter dated July 2006. Recommendations were made to Health Care Providers of the following: 1.Consider the potential for this anomaly if your patient present with a device in a POR state. 2. Consider informing your patients of this risk and advise them to seek attention immediately if they experience a return of pre-implant or more advanced symptoms. 3. Determine whether device replacement is warranted based upon consultation with your patient, review of the patient''s medical history and consideration of the relative risks of abrupt cessation of stimulation versus the risk of a device replacement surgical procedure. 4. Report any malfunction, removal and replacement to Medtronic and FDA suing the medical device reporting system. 5. Acknowledge this communication using the reply form enclosed.

Device

Device Recall Medtronic Kinetra Implantable Neurostimulator
  • Modèle / numéro de série
    serial numbers in the following ranges:   ¿ NFD100006 - NFD100325H ¿ NFD620017S - NFD625737S ¿ NFD200201K - NFD201303K
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide, including USA, Puerto Rico, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Description du dispositif
    Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The dual program model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via DBS extension or DBS leads. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet.
  • Manufacturer
    Medtronic Neurological

Manufacturer

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