Events

Fortify, Unify, Assura, incluging Quadra 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St Jude Medical Inc. 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
    75393
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0115-2017
  • 사례 시작날짜
    2016-10-10
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150190
  • 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
    Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
  • 원인
    St jude medical is recalling implantable cardiac defibrillator (icd) and cardiac resynchronization therapy defibrillator (crt-d) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
  • 조치
    St. Jude Medical, Inc., sent a customer letter to all affected customers to inform them that St. Jude Medical recently announced a global medical device advisory for a subset of their company's Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The letter informs customers that the cause for Premature Battery Depletion is attributed to the formation of lithium clusters within the battery causing a short circuit. There is a possibility that affected devices may lose battery power within days. Thus far, there have been two (2) deaths and ten (10) serious events (fainting) that may have been associated with premature battery depletion. Customers with questions were instructed to contact www.sjm.com/batteryadvisory, (866) 915-5065.

Device

Fortify, Unify, Assura, incluging Quadra
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US (nationwide) and OUS
  • 제품 설명
    Fortify VR, Model No. CD1231-40, CD1231-40Q. || Fortify ST VR, Model No. CD1241-40, CD1241-40Q. || Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. || Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. || Fortify DR, Model No. CD2231-40, CD2231-40Q. || Fortify ST DR, Model No. CD2241-40, CD-2241-40Q, CD2263-40, CD2363-40C, CD2363-40Q. || Fortify Assura DR, Model No. CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q. || Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
  • Manufacturer
    St Jude Medical Inc.

Manufacturer

St Jude Medical Inc.
  • 제조사 주소
    St Jude Medical Inc., 15900 Valley View Ct, Sylmar CA 91342-3577
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA