Events

Medtronic Claria MRI CRT-D SureScan 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Medtronic Inc 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
    20927
  • 사례 시작날짜
    2016-12-08
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • 원인
    Phase 1: manufacturer has identified a device software issue that may occur with all models of claria mri crt-d surescan and amplia mri crt-d surescan devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. as of november 10 , 2016, the manufacturer has observed an overall occurrence rate of 0.38%. but all tachyarrhythmia detection and therapy features remain fully operational. the software issue can be corrected by re-programming the device., the manufacturerwill also address an unrelated transient mode switch behaviour that may occur in mri quadripolar crt-d device models (claria mri™, amplia mri™ and compia mri™)., phase 2: a software update is being developed to address this issue and will be communicated to clinicians once it becomes available, the updated software (sw034 software version 8.2) is now available to correct the issue 1 in the affected claria mri and amplia mri crt-d surescan devices.
  • 조치
    Software to be upgraded

Device

Medtronic Claria MRI CRT-D SureScan
  • 모델명 / 제조번호(시리얼번호)
    Model: DTMA2D4, Affected:
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • 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
    NZMMDSA