Events

Retiro De Equipo (Recall) de Consulta CRT-P (Implantable cardiac pacemaker)

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-2013-RN-00646-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-26
  • 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-2013-RN-00646-1
  • 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 recently identified an issue with a subset of consulta® crt-p devices during production. this issue was identified as a result of an internal investigation that indicated a recent trend of increasing manufacturing rejects related to the weld of a connector bracket. an out-of-specification weld could result in a loss of device hermeticity. loss of hermeticity may allow body fluids to enter the device. this has the potential to compromise functionality resulting in loss of output.
  • Acción
    Medtronic are asking physicians to advise patients to seek medical attention immediately if they experience a return of symptoms related to bradycardia or heart failure. If considering prophylactic device replacement for pace maker dependant patients with an affected device, physicians should carefully assess individual patient circumstances against the known risk of device replacement. Physicians should continue to routinely follow up patients as per standard practice. For more details, please see http://www.tga.gov.au/safety/alerts-device-consulta-130715.htm .

Device

Consulta CRT-P (Implantable cardiac pacemaker)

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