Events

Reveal LINQTM Insertable Cardiac Monitor (ICM) 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Medtronic 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Medtronic has identified an issue with the sensitivity of an algorithm used in the reveal linq icm that may prematurely trigger the rrt alert in some devices. as of february 12, 2016, medtronic has observed an occurrence rate of 0.45% of devices experiencing this issue. battery capacity is not affected and the device will continue to support data collection and manual data transmissions. as stated in reveal linq labeling, the typical device will experience an average of 3 years longevity (refer to the device labelling for the corresponding use conditions). as part of the normal behavior of the device, 30 days after rrt status is reached, reveal linq devices will display an end of service (eos) status at which time the device disables automatic wireless alerts and transmissions. thereafter, patients will still be able to send remote manual transmissions for clinics to receive alerts and stored device data. due to the design of the rrt algorithm, devices are not susceptible to this issue until 200 days (6.5 months) post-implant. as of february 12, 2016 the earliest reported occurrence of rrt is 7.3 months post-implant, with median implant to rrt duration of 16.5 months. .

Device

Reveal LINQTM Insertable Cardiac Monitor (ICM)
  • 모델명 / 제조번호(시리얼번호)
    LNQ11
  • 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
    AMPMDRS