Events

Rappel de Eon, Eon Mini and Brio Implantable Pulse Generator (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-00759-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-08-09
  • 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-00759-3
  • 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
    Reports of heating at the ipg implantation site during charging of the spinal cord and deep brain stimulators. this is an update to the 'hazard alert' letter dated 05 january 2012 . in the updated letter, st. jude is providing updated occurrence rates, informing hospitals and treating clinicians of four instances of patient burns associated with charging the ipgs and additional patient management recommendations.
  • Action
    St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please see http://www.tga.gov.au/safety/alerts-device-ipg-120924.htm

Device

Eon, Eon Mini and Brio Implantable Pulse Generator (IPG) (Implantable Spinal Cord and Deep Brain ...
  • Modèle / numéro de série
    Eon, Eon Mini and Brio Implantable Pulse Generator (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)Eon Implantable Pulse Generator (IPG)Product Code 64-3716 ARTG Number: 127126Eon Mini IPGProduct Code: 65-3788 ARTG Number: 154912Brio IPGProduct code 65-6788 ARTG Number: 164510
  • 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