Events

Retiro De Equipo (Recall) de Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in the management of hydrocephalus

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-2017-RN-00155-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-16
  • 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-2017-RN-00155-1
  • 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
    The identified products may have a rare condition related to the strata valve that can lead to an inaccurate pressure level (pl) reading on the strata indicator tool or stratavarius system. the condition occurs when the magnet inside the valve becomes reverse polarised, which may occur only if a patient has been exposed to 3t mri magnetic field or greater, and biological debris is present to an extent that the valve magnet adjustment mechanism is impacted. medtronic's investigation identifies that a reverse-polarity magnet has a relatively small chance of occurrence (rate: 0.007% over a two year period). over the two year period, a total of five complaints received included three adverse events (three revision surgeries). however, only one revision surgery was confirmed to occur due to the reported product problem. there have been no reports of other instances of disease, illness, or injury.
  • Acción
    Clinicians are advised that the expected adverse health consequences are the same as those experienced during the course of hydrocephalus management (eg. headaches, lethargy, nausea, vomiting), or those related to a revision surgery).The IFU for the products is being updated to include the following verbiage to reinforce the warnings/precautions: “Biological debris inside the valve may impact adjustability, and may lead to adjustment mechanism damage if exposed to 3.0 tesla MRI. If difficulty is experienced adjusting or reading the valve setting, radiographic setting confirmation should be considered. The reading from the Strata II Indicator tool or StrataVarius system may be reversed (180 degrees opposite) from the radiographic image. In this situation, radiographic imaging should be used to determine the setting of the valve.” For further information, please refer to: https://www.tga.gov.au/alert/medtronic-strata-ii-strata-nsc-valves .

Device

Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in th...
  • Modelo / Serial
    Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in the management of hydrocephalusMultiple Catalogue NumbersAll Lot NumbersARTG Numbers: 111909, 129681, 134740, 145335, 145337, 165018, 169054, 169061
  • 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