Events

Retiro De Equipo (Recall) de Medtronic MyCareLink Remote Monitors

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-01009-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-10
  • 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-01009-1
  • 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 is updating the instructions for use (ifu) for medtronic mycarelink remote monitors related to patients monitored on the medtronic carelink network with two (2) or more implanted medtronic heart devices. if a patient has multiple devices, there are potential impacts on the ability to remotely monitor that patient’s heart devices. these potential impacts could lead to missed carealert notifications or device reports. medtronic does not recommend the use of remote monitoring for patients with multiple implanted medtronic heart devices and clinicians should take this into account when implanting an additional medtronic heart device or preparing a patient for remote monitoring. for example, if a medtronic pacemaker is implanted in a patient with an existing reveal linqtm insertable cardiac monitor (icm), it may not be possible to monitor either device remotely.
  • Acción
    Medtronic does not recommend the use of remote monitoring for patients with multiple implanted Medtronic heart devices and clinicians should take this into account when implanting an additional Medtronic heart device1 or preparing a patient for remote monitoring.

Device

Medtronic MyCareLink Remote Monitors
  • Modelo / Serial
    Medtronic MyCareLink Remote Monitors Models: 24950, 25000ARTG Numbers: 215442, 283843 and 235570
  • 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