Events

Retiro De Equipo (Recall) de Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and RestoreSensor Implantable Spinal Cord Stimulators

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-2014-RN-00041-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-23
  • 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-2014-RN-00041-1
  • 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
    1) unexpected loss of stimulation may occur under the following conditions:- switching from a group with two programs to a group with three or four programs where a non-negative contact is shared within the programmed groups. - creating program groups (activa sc only) when a second program is created for the first time.2) under a specific set of conditions (activa sc – models 37602 / 37603 are not affected), typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended:- device reaches a power on reset (por) state. a por may be detected during interrogation with the patient or physician programmer. the patient will experience loss of therapy if a por occurs.- ‘therapy off’ command is sent (by patient programmer, insr, or ‘therapy-stop’ button on the 8840 clinician programmer) to device while the device is making an automatic periodic battery measurement.
  • Acción
    Medtronic does not recommend prophylactic explant of devices because these issues can be addressed non-invasively by the clinician using an 8840 clinician programmer or an Implantable Neurostimulator Recharger using the Physician Recharge Mode. The model 8870 software application card used by the programmer is being updated to version BBR01A by Medtronic field representative. Interrogating patient’s device with the updated software version will automatically update the implanted device software and reduce the probability that a loss of stimulation output will occur. To significantly reduce the likelihood of over stimulation or stimulation in the wrong area, patients should avoid over discharge. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-deep-brain-spinal-cord-stimulation-devices-140204.htm . Thia action has been closed-out on 28/01/2016.

Device

Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and Restor...
  • Modelo / Serial
    Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and RestoreSensor Implantable Spinal Cord StimulatorsActiva PC, Activa RC and Activa SC Implantable Deep Brain StimulatorsModel Numbers: 37601, 37602, 37603, 37612ARTG Numbers: 160118, 188274, 188034, 160117 RestoreUltra and RestoreSensor Implantable Spinal Cord StimulatorsModel Numbers: 37712, 37714ARTG Numbers: 154866, 177594
  • 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