Events

Retiro De Equipo (Recall) de InterStim & InterStim II

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia 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-2015-RN-00071-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-23
  • 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-2015-RN-00071-1
  • 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
    When certain therapy parameters are programmed on the itrel 3 device platform, the use of the cycling feature and the soft start/soft stop feature may result in a negative impact on battery longevity. this impact on longevity is currently not accounted for by longevity estimation tools (including 8870 software and the system eligibility battery longevity (sebl) manual) and may result in an earlier than predicted explant. engineering analysis has shown this to be an issue with the interstim ii (3058) device; however, all itrel 3 platform devices will be included in the scope of the investigation due to product design and potential root cause discussed in section 3.2.
  • Acción
    Medtronic is updating the labelling of the devices to include new information on cycling and its effect on battery longevity. Surgeons are advised that if cycling is being used solely to improve device battery longevity, new information in the product labelling should be considered. This action has been closed-out on 18/07/2016.

Device

InterStim & InterStim II
  • Modelo / Serial
    InterStim & InterStim IIInterStim Model Number: 3023ARTG Number: 125909 InterStim II Model Number: 3058ARTG Number: 136721
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA