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 Boston Scientific Cardiac Rhythm Management Group 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 094 09 18 000
  • 사례 시작날짜
    2018-09-20
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13203
  • 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
    The pacemaker manual describes how increases in pacing requirements or changes in programmed parameters may result in an expected longevity reduction and are considered normal battery depletion. however, hydrogen exposure within the pacemaker’s circuitry may compromise the electrical performance of low voltage capacitors causing current leakage and a moderate acceleration in the rate of battery depletion. because this accelerated depletion does not occur rapidly, a follow-up interval of no more than six months is recommended. boston scientific has determined a liner component to be the source of hydrogen and identified a subset of previously distributed pacemakers that have an elevated potential for exhibiting this behavior. boston scientific pacemakers include automated diagnostic tools, including battery status assessment and estimated longevity predictions, that dynamically adjust based on power consumption. it is important to emphasize that the accuracy of battery status and longevity estimates are not affected by this behavior.

Device

Cardiac Resynchronization Therapy pacemakers (VISIONIST™, ™,) and pacemakers (ACCOLADE™, PROPONE...
  • 모델명 / 제조번호(시리얼번호)
    ACCOLADE™ & ACCOLADE™ MRI : L300, L301, L321 & L310, L311, L331 L200, L221 & L210, L211, L231 ESSENTIO™ & ESSENTIO™ MRI : L100, L101, L121 & L110, L111, L131 VISIONIST™ X4 : U228 VALITUDE™ X : 4 U128
  • 제품 설명
    pacemakers
  • Manufacturer
    Boston Scientific Cardiac Rhythm Management Group

Manufacturer

Boston Scientific Cardiac Rhythm Management Group
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • 제조사 대표
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA