Events

Retiro De Equipo (Recall) de Eon/Eon C/ Eon Mini/ Prodigy Neurostimulation Systems and Octrode/ Quattrode Percutaneous Leads and Accessories

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por St Jude Medical Australia Pty Ltd.

¿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
    RC-2014-RN-01119-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01119-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The indication for st. jude medical’s (sjm) occipital nerve stimulation (ons) therapy for the treatment of intractable chronic migraine is being removed from the product instructions for use. the post market clinical follow up data was not appropriate to demonstrate that the benefit of the therapy outweighs the risk at this time. st. jude medical has advised doctors not to use the eon, eon c, eon mini and prodigy scs devices and associated programmers, as well as the octrode and quattrode leads, for the purpose of occipital nerve stimulation. please note that these products are still available for use as an aid in the management of chronic, intractable pain of the trunk and/or limbs.
  • Acción
    St. Jude Medical has undertaken this action not following the Uniform Recall Procedure for Therapeutic Goods (URPTG) since they have classified this as a product notification. The TGA has classified this change as a hazard alert to inform consumers and health professionals of the changed advice relating to St Jude Medical’s occipital nerve stimulation devices and the latest data relating to their use. Regarding patients who have already been treated for ONS therapy, St Jude Medical is not recommending a change in the way currently implanted patients are followed up. For more information, please see http://www.tga.gov.au/alert/st-jude-medical-implantable-neurostimulators-and-accessories-various-devices .

Device

Eon/Eon C/ Eon Mini/ Prodigy Neurostimulation Systems and Octrode/ Quattrode Percutaneous Leads a...
  • Modelo / Serial
    Eon/Eon C/ Eon Mini/ Prodigy Neurostimulation Systems and Octrode/ Quattrode Percutaneous Leads and AccessoriesEon Neurostimulation System – ARTG 127126Eon C Neurostimulation System – ARTG 158502Eon Mini Neurostimulation System – ARTG 154912Prodigy device - currently is supplied in Australia under the Special Access Scheme (SAS)Octrode Percutaneous Leads - ARTG 132097Quattrode Percutaneous Leads – ARTG 131944
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • 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
    DHTGA