Events

Retiro De Equipo (Recall) de Device Recall Medtronic Activa Deep Brain Stimulation System

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 Inc, Neurological & Spinal Division.

¿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
    34156
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0370-06
  • Fecha de inicio del evento
    2005-11-30
  • Fecha de publicación del evento
    2006-01-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43204
  • 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 safety concern exists regarding the medtronic activa deep brain stimulation system instructions for performing mri (magnetic resonance imaging). medtronic's instructions have until now recommended a use of a displayed mri head specific absorption rate (sar) of not more than 0.4 w/kg. the recommended maximum displayed head sar is now 0.1 w/kg.
  • Acción
    The firm''s recall consists of providing revised instructions for the Activa DBS. The revision modifies the recommended SAR to use during MRI of patients who have an Activa DBS. Use of the Activa DBS is otherwise unaffected by this recall. A Dear Healthcare Provider letter and MRI Radiologist letter were sent on 11/30/05 and 12/05/05 to provide this information.

Device

Device Recall Medtronic Activa Deep Brain Stimulation System
  • Modelo / Serial
    All serial numbers and Lot codes are affected.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and OUS to includeCanada, Europe, Middle East, Africa, Japan, Asia-Pacific, Australia - New Zealand, Latan America
  • Descripción del producto
    Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model 7428 Kinetra Neurostimulator; Models 3387, 3389 DBS Leads; and Models 7482,7495 DBS Extensions. Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via Extension and Lead. These components comprise the implantable portion of the Activa System.
  • Manufacturer
    Medtronic Inc, Neurological & Spinal Division

Manufacturer

Medtronic Inc, Neurological & Spinal Division
  • Dirección del fabricante
    Medtronic Inc, Neurological & Spinal Division, 800 53rd Ave Ne, Columbia Heights MN 55421-1241
  • Source
    USFDA