Events

Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient Programmers 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-2014-RN-00288-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00288-1
  • 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
    Post market review by medtronic has identified that there is the potential for patients to experience spinal cord compression weeks to years after implant of a spinal cord stimulation lead. spinal cord compression can lead to neurological deficit due to the formation of reactive tissue, sometimes with an inflammatory component. the time to onset for spinal cord compression ranges from weeks to over 17 years, and may progress after lead removal.
  • 조치
    Medtronic is advising surgeons that prophylactic removal of the leads is not recommended. Awareness of this adverse event can lead to early detection and prevention of permanent neurological impairment. If a patient presents with new neurological deficit, spinal cord compression due to reactive tissue mass formation should be considered as a potential cause. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-spinal-cord-140317.htm .

Device

Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient Program...
  • 모델명 / 제조번호(시리얼번호)
    Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient ProgrammersMultiple model numbers affectedARTG Numbers: 141860, 154866, 141861, 177594, 215751, 215748, 215749, 215750, 143034, 141857, 137079, 123240, 123242, 137080, 123241, 123243, 214838, 214839, 137348, 143035, 141858, 114947, 119320, 163895, 148397, 219258, 219259, 134080, 137439, 139649, 177036 and 214421
  • 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