Events

Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 LivaNova Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00929-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-07-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00929-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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...
  • 모델명 / 제조번호(시리얼번호)
    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