Events

Rappel de Axium Neurostimulator Leads (MN20450-50AU, MN20450-90AU)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Spinal Modulation 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-2014-RN-00531-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-23
  • 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-2014-RN-00531-1
  • 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
    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)
  • Modèle / numéro de série
    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