Events

Retiro De Equipo (Recall) de EON MINI NEUROSTIMULATION SYSTEM - IMPLANTABLE PULSE GENERATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ABBOTT MEDICAL CANADA INC..

¿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
    24582
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-07-27
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Product investigation and analysis concerning reports of the inability to communicate or recharge the eon mini ipg has identified weld cracks in the ipg's inner battery as the cause of this issue. there is a need to more frequently maintain and replace welding fixtures to assure complete alignment between the welding apparatus and the battery. there is no exposure of electrolyte material to the patient.

Device

EON MINI NEUROSTIMULATION SYSTEM - IMPLANTABLE PULSE GENERATOR
  • Modelo / Serial
    Model Catalog: 3788 (Lot serial: 13709418 13710437 13725081); Model Catalog: 3788 (Lot serial: 13691790 13691827 13691967); Model Catalog: 3788 (Lot serial: 13691341 13648229 13691401); Model Catalog: 3788 (Lot serial: SERIAL NUMBERS:13548109); Model Catalog: 3788 (Lot serial: 13691522 13672787 13691786); Model Catalog: 3788 (Lot serial: 13656051 13672978 13673518); Model Catalog: 3788 (Lot serial: 13709498 13523004 13545855)
  • Descripción del producto
    EON MINI NEUROSTIMULATION SYSTEM-IMPLANTABLE PULSE GENERATOR
  • Manufacturer
    ABBOTT MEDICAL CANADA INC.

Manufacturer

ABBOTT MEDICAL CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC