Events

Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in the management of hydrocephalus 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-2017-RN-00155-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00155-1
  • 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
    The identified products may have a rare condition related to the strata valve that can lead to an inaccurate pressure level (pl) reading on the strata indicator tool or stratavarius system. the condition occurs when the magnet inside the valve becomes reverse polarised, which may occur only if a patient has been exposed to 3t mri magnetic field or greater, and biological debris is present to an extent that the valve magnet adjustment mechanism is impacted. medtronic's investigation identifies that a reverse-polarity magnet has a relatively small chance of occurrence (rate: 0.007% over a two year period). over the two year period, a total of five complaints received included three adverse events (three revision surgeries). however, only one revision surgery was confirmed to occur due to the reported product problem. there have been no reports of other instances of disease, illness, or injury.
  • 조치
    Clinicians are advised that the expected adverse health consequences are the same as those experienced during the course of hydrocephalus management (eg. headaches, lethargy, nausea, vomiting), or those related to a revision surgery).The IFU for the products is being updated to include the following verbiage to reinforce the warnings/precautions: “Biological debris inside the valve may impact adjustability, and may lead to adjustment mechanism damage if exposed to 3.0 tesla MRI. If difficulty is experienced adjusting or reading the valve setting, radiographic setting confirmation should be considered. The reading from the Strata II Indicator tool or StrataVarius system may be reversed (180 degrees opposite) from the radiographic image. In this situation, radiographic imaging should be used to determine the setting of the valve.” For further information, please refer to: https://www.tga.gov.au/alert/medtronic-strata-ii-strata-nsc-valves .

Device

Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in th...
  • 모델명 / 제조번호(시리얼번호)
    Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in the management of hydrocephalusMultiple Catalogue NumbersAll Lot NumbersARTG Numbers: 111909, 129681, 134740, 145335, 145337, 165018, 169054, 169061
  • 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