Events

Rappel de Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par LivaNova Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00929-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-07-09
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00929-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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