Events

Retiro De Equipo (Recall) de DBS Lead Depth Stop DBS Lead Depth Stop supplied with Medtronic Models 3387, 3389 and 3391

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-00422-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-03-28
  • 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-00422-1
  • 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
    Medtronic have received three complaints from physicians regarding the dbs depth stop not being adequately secured to the lead. in two of the three complaints received, this resulted in initial dbs lead placement beyond the intended target, which was identified via intraoperative imaging and corrected with no report of patient harm. in the third instance, the issue was identified prior to lead insertion. analysis of these returned products indicate the threaded area of the depth stop screw did not extend far enough to allow it to fully secure the lead in the depth stop causing the slippage of the lead through the depth stop.
  • Acción
    Medtronic is requesting surgeons who suspect that the depth stop is not tightening adequately onto the lead to discontinue use the affected device but instead, to complete the procedure using a depth stop from another Medtronic DBS lead kit. Surgeons are further requested to check the stimulation effect during the implant procedure and use imaging techniques to confirm lead placement, as stated in the DBS lead implant manual. For devices already implanted, surgeons are advised that no action is needed (since lead placement at the intended target location is expected to have been confirmed through intraoperative test stimulation, imaging, and/or therapy effectiveness).

Device

DBS Lead Depth Stop DBS Lead Depth Stop supplied with Medtronic Models 3387, 3389 and 3391
  • Modelo / Serial
    DBS Lead Depth StopDBS Lead Depth Stop supplied with Medtronic Models 3387, 3389 and 3391All leads with a use by date of 2021-03-01 or earlierARTG Numbers: 137374, 137138 and 174469 respectively
  • Clasificación del producto
    Neurological Devices
  • 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