Events

Rappel de Eon Mini and Brio Implantable Pulse Generators (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par St Jude Medical Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2012-RN-00784-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-08-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00784-3
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    This is an update to the 'hazard alert' letter dated 24 may 2011, pertaining to the eon mini model 3788 and brio model 6788 implantable pulse generators (ipgs) inner battery cracking issues. st. jude medical received reports eon mini and brio ipgs that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant.
  • Action
    St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please refer to the TGA Website http://www.tga.gov.au/safety/alerts-device-ipg-120924.htm

Device

Eon Mini and Brio Implantable Pulse Generators (IPG) (Implantable Spinal Cord and Deep Brain Stim...
  • Modèle / numéro de série
    Eon Mini and Brio Implantable Pulse Generators (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)Eon MiniProduct Code: 65-3788ARTG Number: 154912Brio IPG Product Code: 65-6788ARTG Number: 164510
  • Classification du dispositif
    Neurological Devices
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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