Events

Axium Neurostimulator Leads (MN20450-50AU, MN20450-90AU) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Spinal Modulation 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-2014-RN-00531-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00531-1
  • 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
    Over 2000 drg leads have been implanted in patients worldwide. at this time, there have been 10 reports of lead breakage during attempted lead removal, resulting in lead fragments remaining implanted in the patient. to date, there have not been any reported complications or long-term sequelae surrounding these events. during lead removal of a permanently implanted lead, the spinal modulation implant instructions and warnings must be followed to help prevent lead breakage.
  • 조치
    Spinal Modulation is undertaking this action to provide additional information and clarify the steps necessary to ensure safe lead removal after permanent implantation. Some of these methods are described in the “Physician Implant Manual". The additional information that has already been identified in the letter will be included in the future releases of the Physician Implant Manual.

Device

Axium Neurostimulator Leads (MN20450-50AU, MN20450-90AU)
  • 모델명 / 제조번호(시리얼번호)
    Axium Neurostimulator Leads (MN20450-50AU, MN20450-90AU) KIT IMPLANT LEAD 50CM Model MN20450-50AU KIT IMPLANT LEAD 90CM Model MN20450-90AU ARTG number: 202325
  • Manufacturer
    Spinal Modulation Pty Ltd

Manufacturer

Spinal Modulation Pty Ltd
  • Source
    DHTGA