Events

PLATINIUM 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 LivaNova PLC 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
    Potential programmer screen freeze during a 30hz pacing burst launched using rf telemetry as of june 30, 2016, livanova received four (4) reports (i.E. 0.087%) of programmer screen freeze during 30hz pacing while the test was launched using rf telemetry. the space bar of the programmer keyboard, as well as the buttons on the programmer screen remained unresponsive (buttons grayed out) during the delivery of the 30hz burst, making it impossible to stop the test before the end of the programmed burst duration2. if ventricular fibrillation is effectively induced, and the user wants to prematurely interrupt the 30hz pacing, there can be a delay in the delivery of the shock therapy which may prolong the syncope. however, the shock therapy will in all cases be effectively delivered in accordance with the induction sequence that was initially programmed: at the end of the programmed 30hz burst duration, antiarrhythmia functions are reactivated (arrhythmia detection algorithms, charging and shock therapy). this issue was only encountered during implantation procedures. .

Device

PLATINIUM
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    LivaNova PLC

Manufacturer

LivaNova PLC