Events

Retiro De Equipo (Recall) de Device Recall Medtronic Kinetra Implantable Neurostimulator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Neurological.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    35967
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0290-2007
  • Fecha de inicio del evento
    2006-07-19
  • Fecha de publicación del evento
    2006-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-04-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47276
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    neurostimulator - Product Code MHY
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    serial numbers in the following ranges:   ¿ NFD100006 - NFD100325H ¿ NFD620017S - NFD625737S ¿ NFD200201K - NFD201303K
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Descripción del producto
    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
  • Dirección del fabricante
    Medtronic Neurological, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA