Events

Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan Amplia MRI CRT-D SureScan/Amplia MRI Quad CRT-D 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-2016-RN-01604-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-12-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01604-1
  • 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
    Medtronic is writing to inform physicians about a software issue that could result in the loss of lv pacing that occurs following a specific device programming sequence. if it occurs, this issue can be corrected by re-programming the device. all tachyarrhythmia detection and therapy features remain fully operational. the issue can only occur in devices that have been programmed from managed ventricular pacing (mvp) mode to a pacing mode with adaptivcrt enabled. when a patient with adaptivcrt enabled (shipped setting) is subsequently programmed to mvp mode and then re-programmed back to ddd or dddr, adaptivcrt is not re-enabled. when this programming sequence occurs, lv pacing is not delivered, despite parameters indicating adaptivcrt is enabled. through 10 november 2016, two events have been reported to medtronic related to this issue. a review of the data revealed an overall occurrence rate of 0.38%. medtronic has not received any reports of patient injury related to this issue.
  • 조치
    A software update is being developed by Medtronic to address this issue in Claria MRI and Amplia MRI devices. This software update will also address an unrelated transient mode switch behaviour in all Quadripolar models of Claria MRI, Amplia MRI, and Compia MRI CRT-D SureScan devices. Further information will be communicated once the software update receives applicable regulatory approvals. Until the software update has been approved and the affected models receive the update, Physicians are advised to follow the programming recommendations in the customer letter. These recommendations also apply to any new device implants.

Device

Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan Amplia MRI CRT-D SureScan/Amplia MRI Quad...
  • 모델명 / 제조번호(시리얼번호)
    Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan Amplia MRI CRT-D SureScan/Amplia MRI Quad CRT-D SureScanModels: DTMB2D1, DTMB2D4, DTMB2QQClaria MRI CRT-D SureScan/ Claria MRI Quad CRT-D SureScan Models: DTMA2D1, DTMA2D4, DTMA2Q1, DTMA2QQMultiple ARTG numbers
  • 의료기기 분류등급
    Cardiovascular 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