Events

Medtronic StrataMR Adjustable Valves & Shunts 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-00297-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-03-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00297-1
  • 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
    Specific stratamr adjustable valves & shunts may experience a condition which may, in limited circumstances, affect the flow resistance in the valve and result in underdrainage of cerebrospinal fluid (csf). the condition can occur when the valve mechanism is adjusted to a position that causes a higher than intended flow resistance. this higher than intended flow resistance is a result of the mri resistance key on the bottom of the valve’s rotor mechanism being placed on top of one of the mri resistance walls, instead of in one of the pressure setting wells. the incorrect valve rotor orientation can be caused by misalignment and/or off-center positioning of the stratamr locator tool, relative to the valve mechanism during the valve adjustment process. this condition may result in headaches, nausea, vomiting and lethargy. if left untreated underdrainage has the potential to lead to coma and death. to date, there have been no reports of death.
  • 조치
    Customers are advised to discard and return any unused units to Medtronic. For products that have been implanted in patients, clinicians are reminded that for continued patient care that it is critical to properly align and center the Locator Tool over the valve mechanism to ensure that the valve is set at the desired pressure. Instructions that will aid in proper technique are included in the Instructions for Use and reiterated in the customer letter.

Device

Medtronic StrataMR Adjustable Valves & Shunts used in the management of hydrocephalus
  • 모델명 / 제조번호(시리얼번호)
    Medtronic StrataMR Adjustable Valves & Shunts used in the management of hydrocephalusStrataMR Valve, SmallCatalogue Number: 42955Serial Numbers: E06139, E06476, E09475, E12753, E13484, E13641, E18556, E18557, E18558StrataMR Valve, RegularCatalogue Number: 42965Serial Numbers: E06016, E06138, E06412, E09619,E12266, E12952, E18559, E18560Strata MR Shunt Assembly, SmallCatalogue Number: 46955Serial Number: E12932ARTG Numbers: 129681, 134740
  • 의료기기 분류등급
    Neurological Devices
  • 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