Events

Retiro De Equipo (Recall) de 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
    35110
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0861-06
  • Fecha de inicio del evento
    2006-04-04
  • Fecha de publicación del evento
    2006-05-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45370
  • 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
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor - Product Code MHY
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    NFD621879S, NFD621891S, NFD621901S, NFD621981S, NFD621976S, NFD622170S, NFD622185S, NFD622189S, NFD622201S, NFD622247S, NFD622279S, NFD623035S, NFD622345S, NFD622349S, NFD622372S, NFD622382S, NFD622387S, NFD622400S, NFD622414S, NFD622466S,  NFD622542S, NFD622564S, NFD622629S, NFD622664S
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    USA--States of CA, OR, PA. Internationally -Belgium, France, Germany, Italy, Spain, Switzerland, United Kingdom
  • Descripción del producto
    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
  • Dirección del fabricante
    Medtronic Neurological, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA