Device Recall Guidant ASSURE ICD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific CRM Corp 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
    44793
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0049-2008
  • 사례 시작날짜
    2007-03-16
  • 사례 출판 날짜
    2007-11-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2007-11-23
  • 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
    Implantable Cardioverter Defibrillator, ICD. - Product Code LWP
  • 원인
    Atypical charge time behavior: 1)-end of life (eol) or eri is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- extended eri charge time limits: charge times during mid-life may remain below a normal extension of the eri charge time . ****** prophylactic replacement of these devices prior to eri is not recommended. as stated in the product.
  • 조치
    A Product Update titled "ERI Charge Time Limit Extended During Mid-Life and Mid-Life Display of Replacement Indicators", dated 03/10/2007 was posted to Company's website on 03/13/2007. A CRM Product News letter was sent to physicians beginning 03/16/2007. The CRM Product News Letter gave an overview of the content of the Product Update and stated the web location for finding the complete Product Update. The Product Update identified affected devices, gave an overview of normal charge time behavior at mid-life for specific ICD and CRT-D devices. The letter also described the atypical charge time behavior, projected rate of mid-life display of replacement indicators and Patient Management Considerations. ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product Update, "Devices that have triggered charge time-based ERI or EOL during mid-life have several months, and in most cases more than one year of remaining battery voltage and capacity, which allows the devices in this pattern to continue to provide brady and LV pacing and maximum energy shocks. However, if ERI or EOL is triggered, device replacement should be scheduled."*****Recalled units only cover devices implanted prior to July 2005****

Device

  • 모델명 / 제조번호(시리얼번호)
    Model B301: B301/100002, B301/100003, B301/100004, B301/100006, B301/100007, B301/100008, B301/100010, B301/100012, B301/100013, B301/100014, B301/100016, B301/100019, B301/100020, B301/100021, B301/100022, B301/100024, B301/100025, B301/100027, B301/100030, B301/100031, B301/100032, B301/100034, B301/100037, B301/100039, B301/100043, B301/100044, B301/100045, B301/100046, B301/100048, B301/100050, B301/100051, B301/100053, B301/100054, B301/100056, B301/100062, B301/100063, B301/100064, B301/100067, B301/100069, B301/100070, B301/100073, B301/100074, B301/100075, B301/100076, B301/100079, B301/100080, B301/100081, B301/100082, B301/100083, B301/100084, B301/100087, B301/100088, B301/100089, B301/100090, B301/100091, B301/100092, B301/100094, B301/100096, B301/100099, B301/100100, B301/100101, B301/100102, B301/100103, B301/100104, B301/100105, B301/100106, B301/100108, B301/100111, B301/100112, B301/100113, B301/100114, B301/100115, B301/100116, B301/100117, B301/100118, B301/100120, B301/100122, B301/100125, B301/100126, B301/100128, B301/100129, B301/100130, B301/100131, B301/100132, B301/100134, B301/100135, B301/100136, B301/100137, B301/100139, B301/100140, B301/100141, B301/100142, B301/100143, B301/100144, B301/100145, B301/100146, B301/100147, B301/100148, B301/100149, B301/100153, B301/100154, B301/100155, B301/100158, B301/100159, B301/100161, B301/100162, B301/100164, B301/100165, B301/100166, B301/100167, B301/100169, B301/100170, B301/100172, B301/100173, B301/100174, B301/100176, B301/100180, B301/100181, B301/100182, B301/100183, B301/100185, B301/100186, B301/100187, B301/100188, B301/100189, B301/100191, B301/100193, B301/100194, B301/100195, B301/100196, B301/100197, B301/100200, B301/100203, B301/100204, B301/100205, B301/100206, B301/100208, B301/100209, B301/100210, B301/100211, B301/100213, B301/100215, B301/100216, B301/100218, B301/100221, B301/100222, B301/100223, B301/100224, B301/100226, B301/100227, B301/100230, B301/100234, B301/100235, B301/100236, B301/100238, B301/100239, B301/100242, B301/100243, B301/100244, B301/100245, B301/100247, B301/100249, B301/100253, B301/100255, B301/100258, B301/100260, B301/100264, B301/100271, B301/100272, B301/100273, B301/100279, B301/100280, B301/100285, B301/100288, B301/100290, B301/100293, B301/100298, B301/100315, B301/100317, B301/100318
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide
  • 제품 설명
    Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillator, ICD. (This model is not available in the USA) Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA