Events

Retiro De Equipo (Recall) de Device Recall iCon Patient Programmer

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 Neuromodulation.

¿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
    48752
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2322-2008
  • Fecha de inicio del evento
    2008-05-12
  • Fecha de publicación del evento
    2008-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72059
  • 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, implantable, for incontinence - Product Code EZW
  • Causa
    Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. the application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.
  • Acción
    A letter was sent to each account telling them of the issue and to let them know that Medtronic is retrieving the affected devices. Medtronic Reps were to visit affected accounts to notify them of the recall, locate the affected device and return it. Rep is to complete the reply card and fax to Medtronic Neuromodulation. If you have questions, contact your Medtronic representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Device

Device Recall iCon Patient Programmer
  • Modelo / Serial
    serial numbers: NJD058707N, NJD062024N, NJD063259N, and NJD063324N
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    GA, MO, NC, TX no OUS distribution
  • Descripción del producto
    Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Dirección del fabricante
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA