Events

Retiro De Equipo (Recall) de Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por LivaNova Australia 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-2018-RN-00929-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-07-09
  • 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-2018-RN-00929-1
  • 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
    On a subset of platinium icd and crt-d devices, a specific hardware configuration was identified as potentially defective over time, leading to overconsumption, immediately followed by loss of pacing and sensing capabilities in all cavities. as a result of the loss of sensing capability, the device cannot identify an arrhythmia that would require a defibrillation shock therapy.No permanent injury or death has been reported as a result of this issue.
  • Acción
    Microport CRM is initiating a removal of the non-implanted Platinium devices that may present with this hardware failure and providing recommendations for managing implanted patients; and In order to mitigate the potential risks associated with the loss of the device pacing and sensing capabilities, Microport CRM recommends physicians follow-up the patients at the periodicity already stated in the implant manual.

Device

Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CR...
  • Modelo / Serial
    Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)PLATINIUM VR 1210ARTG No: 282817PLATINIUM VR 1240ARTG No: 282816PLATINIUM DR 1510ARTG No: 282818PLATINIUM DR 1540ARTG No: 282819PLATINIUM CRT-D 1711ARTG No: 282820PLATINIUM CRT-D 1741ARTG No: 282821PLATINIUM SONR CRT-D 1811ARTG No: 282822PLATINIUM SONR CRT-D 1841ARTG No: 282823
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd