Events

Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2016-12-20
  • 사례 출판 날짜
    2016-12-20
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161220.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic amplia mri crt-d surescan and claria mri crt-d surescan the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning amplia mri cardiac resynchronization therapy devices (crt-d) surescan and claria mri crt-d surescan, manufactured by medtronic. according to the manufacturer, there is 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 the manufacturer related to this issue. a review of the data revealed an overall occurrence rate of 0.38%. the manufacturer has not received any reports of patient injury related to this issue. a software update is being developed by the manufacturer 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. until the software update has been approved and the affected models receive the update, physicians are advised to follow the programming recommendations provided by the manufacturer. these recommendations also apply to any new device implants. according to the local supplier, the affected products [ampila mri crt-d (dtmd2d4) and ampila mri quad crt-d surescan (dtmb2qq)] are distributed in hong kong. for details, please refer to the tga website: https://www.Tga.Gov.Au/alert/medtronic-crt-ds-various-models if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 december 2016.

Device

Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH