QuickFlex, QuickFlex XL 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St Jude Medical CRMD 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61656
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1483-2012
  • 사례 시작날짜
    2012-04-03
  • 사례 출판 날짜
    2012-05-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-07-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - Product Code NIK
  • 원인
    Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these quicksite and quickflex leads.
  • 조치
    A recall communication was initiated on 4/3/12 with St. Jude Medical forwarding a Medical Device Advisory to all doctors who have received the St. Jude QuickSite and QuickFlex Left Ventricular CRT leads models 1056T, 1058T, 1156T, and 1158T. The letter provides the doctors with the problems identified and actions to be taken. Doctors with any questions or concerns are instructed to contact their local St. Jude Medical representative or their Technical Services Department at (800) 722-3774. A Physician Device Advisory Notice for the QuickSite and QuickFlex Left Ventricular CRT Leads was issued on 4/3/12 to physicians who have received the recalled products. The notice provides the physicians with the problem identified and actions to be taken. Physicians are instructed to return any packaged product in hospital inventory to SJM Sales Representatives. For implanted product, due to the nature of the issue, externalized conductors may be observed with no electrical or performance anomalies. Therefore, prophylactic explant is not recommended. It is recommended that physicians continue to monitor their patients' implanted system at regularly scheduled intervals. A Medical Advisory and Inventory Management Information letter was sent on 4/3/12 to hospital administrators to notify them of the problems identified and the actions to be taken.

Device

  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- Algeria, Argentina, Australia, Austria, Bahrain, Balkan, Baltic, Belarus, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Montenegro, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Paraguay, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Serbia Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, US, Venezuela, and Yemen.
  • 제품 설명
    Cardiac Resynchronization Therapy (CRT) Leads || Trade Name: QuickFlex, QuickFlex XL || Model Numbers: QuickFlex and QuickFlex XL: model 1156T, model 1158T || Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead.
  • Manufacturer

Manufacturer

  • 제조사 주소
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA