Events

Medtronic Sprint Fidelis Defibrillation Leads 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Medtronic Inc. 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 연번
    V3710
  • 날짜
    2007-10-15
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/recall-of-medtronic-sprint-fidelis-defibrillation-leads&id=bb99f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • 데이터 추가 비고
  • 원인
    The irish medicines board (imb) today confirmed that medtronic inc. has voluntarily suspended worldwide distribution of the sprint fidelis family of defibrillation leads and is recalling any unused leads because of the potential for lead fractures.  the vast majority of sprint fidelis leads should continue to function normally; however, where a lead actually breaks, or ‘fractures’, this may result in an audible alert or may cause inappropriate shocks and / or loss of device function. the imb are advising any patients who believe they may have a sprint fidelis lead to contact their cardiologists and seek medical advice. following consultation with an independent group of experts, medtronic inc. are currently recommending that patients do not require automatic replacement of sprint fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. medtronic inc. has been in contact with cardiologists to inform them of the issue and provide them with follow up recommendations.  medtronic inc. recommends against the further implantation of sprint fidelis leads (models: 6930, 6931, 6948, 6949).  it is important to note that the sprint fidelis leads are not used with standard pacemaker devices but are used only with more specialist implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy – defibrillators (crt-ds) devices. medtronic inc. has informed the imb that since october 2004 approximately 1178 sprint fidelis leads have been implanted in patients in 14 centres in ireland.  the imb are advising any patients who believe they may have a sprint fidelis lead to contact their cardiologists and seek medical advice. medtronic inc. is continuing to investigate the root cause of the lead fractures.  the imb will continue to be in close communication with the manufacturer to ensure that this recall is conducted efficiently in ireland.  recall of medtronic sprint fidelis defibrillation leads.

Device

Medtronic Sprint Fidelis Defibrillation Leads
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 제품 설명
    Recall of Medtronic Sprint Fidelis Defibrillation Leads
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • 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
    HPRA