Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Medtronic Cardiovascular Revascularization & Surgical Therap 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 057 05 16 000
  • 사례 시작날짜
    2016-05-09
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9332
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Medtronic has confirmed four (4) instances of loss of therapy during recharging of a restoresensor implantable neurostimulator, for a rate of 0.007% (4 / 54.516) of devices distributed worldwide. by design, stimulation therapy turns off when battery voltage depletes below 3.575 volts. in the reported occurrences, a charging session was terminated prior to obtaining a recharge threshold voltage of 3.615, which triggered a rapid battery depletion state. as a result of the rapid battery discharge state, the implanted neurostimulators depleted to 1.925 volts (a state of overdischarge) in one to two days rather than the typical 30 days. insufficient coupling (charging efficiency) between the recharger and the implanted neurostimulator during the recharge session was found to be a key factor in the reported events. note that once a device is in the over discharge state, therapy is interrupted with return of patient symptoms and can only be restored using the physician recharge mode of the recharger. as described in labeling, if three occurrences of overdischarge occur, the neurostimulator will trigger end of life, and must be replaced to resume therapy.

Device

Neurostimulator system for pain therapy

Manufacturer

Medtronic Cardiovascular Revascularization & Surgical Therap
  • 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.
  • 제조사 대표
    Gulf Medical Co.
  • Source
    SFDA