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 SA 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 058 12 16 001
  • 사례 시작날짜
    2017-05-16
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11034
  • 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 identified an issue that may occur with all models of claria mri™ crt-d surescan™ and amplia mri™ crt-d surescan™ devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. whenever a patient with adaptivcrt* enabled (shipped setting) is subsequently programmed to mvp (managed ventricular pacing) mode and then re-programmed back to ddd or dddr, adaptivcrt is not re-enabled. when this programming sequence occurs, lv pacing is not delivered, despite parameters indicating adaptivcrt is enabled. this will result in rv only pacing which may be undesirable for the patient. lv pacing will remain disabled until a specific programming sequence is manually completed. * this feature adjusts crt parameter values automatically while the patient is ambulatory. if adaptivcrt is programmed to adaptive bi-v and lv, the feature can switch automatically between biventricular pacing and lv-only pacing.

Device

Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™
  • 모델명 / 제조번호(시리얼번호)
    Model Name: Product Model - Amplia MRI™ CRT-D SureScan™: ( DTMB2D1, DTMB1D4, DTMB2D4 ) - Amplia MRI™ Quad CRT-D SureScan™: ( DTMB2Q1, DTMB1QQ, DTMB2QQ) - Claria MRI™ CRT-D SureScan™: ( DTMA2D1, DTMA2D4) - Claria MRI™ Quad CRT-D SureScan™: (DTMA2Q1, DTMA2QQ )
  • 제품 설명
    Cardiac resynchronization therapy implantable defibrillator
  • Manufacturer
    Medtronic SA

Manufacturer

Medtronic SA
  • 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
    Medtronic Saudi Arabia
  • Source
    SFDA