Events

Recall of Eon/Eon C/ Eon Mini/ Prodigy Neurostimulation Systems and Octrode/ Quattrode Percutaneous Leads and Accessories

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by St Jude Medical Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-01119-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01119-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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...
  • Model / 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
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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