Events

Retiro De Equipo (Recall) de Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM)

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-2016-RN-00644-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-07
  • 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-2016-RN-00644-1
  • 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
    In february 2016, medtronic issued a medical device hazard alert communication that indicated medtronic reveal linq insertable cardiac monitors (icms) could experience a performance issue that affects the recommended replacement time (rrt) alert. this original communication named phase 1, also explained that medtronic was awaiting a software update to address this issue.Medtronic has now developed the necessary software and is ready to begin applying this update to all reveal linq icms which constitutes phase 2 of the alert.Once installed, this software update will reset rrt & end of service (eos) status and re-enable wireless transmissions for devices that have experienced premature rrt /eos. the update will also prevent the occurrence of premature rrt alerts due to this issue. refer to the original communication for additional details (rc-2016-rn-00202-1).
  • Acción
    Medtronic will be providing a software update as a permanent correction. For more information, please see https://www.tga.gov.au/alert/medtronic-reveal-linq-insertable-cardiac-monitor. This action has been closed-out on 17/02/2017.

Device

Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM)
  • Modelo / Serial
    Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) Model LNQ11 ARTG Number: 218791
  • 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