Events

InterStim & InterStim II 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-2015-RN-00071-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00071-1
  • 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
    When certain therapy parameters are programmed on the itrel 3 device platform, the use of the cycling feature and the soft start/soft stop feature may result in a negative impact on battery longevity. this impact on longevity is currently not accounted for by longevity estimation tools (including 8870 software and the system eligibility battery longevity (sebl) manual) and may result in an earlier than predicted explant. engineering analysis has shown this to be an issue with the interstim ii (3058) device; however, all itrel 3 platform devices will be included in the scope of the investigation due to product design and potential root cause discussed in section 3.2.
  • 조치
    Medtronic is updating the labelling of the devices to include new information on cycling and its effect on battery longevity. Surgeons are advised that if cycling is being used solely to improve device battery longevity, new information in the product labelling should be considered. This action has been closed-out on 18/07/2016.

Device

InterStim & InterStim II
  • 모델명 / 제조번호(시리얼번호)
    InterStim & InterStim IIInterStim Model Number: 3023ARTG Number: 125909 InterStim II Model Number: 3058ARTG Number: 136721
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “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