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
  • 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
  • 1 Event

Fabricant

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