Events

Recall of Axium Neurostimulator Leads (MN20450-50AU, MN20450-90AU)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Spinal Modulation 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-00531-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00531-1
  • 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
    Over 2000 drg leads have been implanted in patients worldwide. at this time, there have been 10 reports of lead breakage during attempted lead removal, resulting in lead fragments remaining implanted in the patient. to date, there have not been any reported complications or long-term sequelae surrounding these events. during lead removal of a permanently implanted lead, the spinal modulation implant instructions and warnings must be followed to help prevent lead breakage.
  • Action
    Spinal Modulation is undertaking this action to provide additional information and clarify the steps necessary to ensure safe lead removal after permanent implantation. Some of these methods are described in the “Physician Implant Manual". The additional information that has already been identified in the letter will be included in the future releases of the Physician Implant Manual.

Device

Axium Neurostimulator Leads (MN20450-50AU, MN20450-90AU)
  • Model / Serial
    Axium Neurostimulator Leads (MN20450-50AU, MN20450-90AU) KIT IMPLANT LEAD 50CM Model MN20450-50AU KIT IMPLANT LEAD 90CM Model MN20450-90AU ARTG number: 202325
  • Manufacturer
    Spinal Modulation Pty Ltd

Manufacturer

Spinal Modulation Pty Ltd
  • Source
    DHTGA