Events

Temporary endocardial stimulation cable system 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Medtronic France S 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
    R1606-252
  • 사례 연번
    2005V-0003497
  • 날짜
    2016-05-15
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • 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 reports that it has detected that the referenced device does not meet the requirements of section 8.5.2.3 of the international standard iec 60601-1 and the corresponding provision 21 crf 898 of the fda in relation to the design standards to prevent the connection of the patient's cable to possibly dangerous voltages, this situation could be possible if the instructions for use are not followed properly, leading to the potential occurrence of adverse events on patients.

Device

Temporary endocardial stimulation cable system
  • 모델명 / 제조번호(시리얼번호)
    6416, all batches manufactured after May 1, 2014
  • 제품 설명
    The MEDTRONIC model 6416 temporary transvenous stimulation cable system has a bipolar active fixation cable and a lubri- cated lubricant guide catheter. This system has been designed for temporary intracardiac stimulation and the recording of electrocardiograms. It is a disposable system, for temporary use with only one patient, with an estimated implant duration of 7 days or less.
  • Manufacturer
    Medtronic France S

Manufacturer

Medtronic France S
  • 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