Events

REVEAL LINQ Insertable Heart Monitor 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Medtronic, Inc. || Medtronic Europe S. A.R.L 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
  • 사례 ID
    I1612-585
  • 사례 연번
    2014DM-0011606
  • 날짜
    2016-12-16
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=108
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer states that it has identified a problem with the sensitivity of an algorithm used in the (icms), which may prematurely trigger the replacement time alert (rrt) on some devices. as of february 12, 2016, medtronic states that it has observed an occurrence rate of 0.45% of the devices that experience this problem, leading to the occurrence of possible serious adverse events on the patient.

Device

REVEAL LINQ Insertable Heart Monitor
  • 모델명 / 제조번호(시리얼번호)
    LNQ11
  • 제품 설명
    The REVEAL LINQ cardiac monitor from MEDTRONIC is a programmable device that continuously monitors the ECG and other physiological parameters of the patient. The device registers cardiac in response to the activation of the patient and the arrhythmias that have been detected automatically. It is indicated in the following cases: Patients with clinical syndromes osituations with greater risk of cardiac arrhythmias. Patients who experience transient symptoms that may suggest cardiac arrhythmia.
  • Manufacturer
    Medtronic, Inc. || Medtronic Europe S. A.R.L

Manufacturer

Medtronic, Inc. || Medtronic Europe S. A.R.L
  • 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
    NIDFSINVIMA