Events

Retiro De Equipo (Recall) de Axium Neurostimulator Leads (MN20450-50AU, MN20450-90AU)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Spinal Modulation Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00531-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00531-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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)
  • Modelo / 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