Events

CONTAK RENEWAL 3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Guidant Corporation 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
    35166
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0825-06
  • 사례 시작날짜
    2006-04-07
  • 사례 출판 날짜
    2006-05-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-04-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45443
  • 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
    77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. this would likely render the device non-functional, resulting in no output and/or telemetry communications.
  • 조치
    Guidant Sales Representatives are retrieving non-implanted devices April 10-12, 2006. If a device is implanted the physician is sent an Urgent Medical Device Safety Information & Corrective Action letter, April 11-14, 2006. This letter describes the issue, states that Guidant is retrieving all non-implanted devices and that Guidant is currently conducting tests on retrieved devices. Physicians will be advised once more information is available.

Device

CONTAK RENEWAL 3
  • 모델명 / 제조번호(시리얼번호)
    model H170 serial numbers: 364406, 364446, 364542, 364576, 364582, 364586, 364587, 364590, 364591, 364593, 364595, 364596, 364597, 364599, 364600, 364601, 364602, 364604, 364605, 364606, 364607, 364608, 364609, 364611, 364613, 364615, 364623, 364625, 364632, 364633, 364634, 364636, 364643, 364680, 364732, 364735, 364752.  model H175 serial numbers: 315437, 315438, 315452, 315454, 315455, 315456, 315461, 315462, 315464, 315470, 315473, 315480, 315482, 315489, 315496, 315497, 315500, 315580, 315588, 315605.   model H177 serial number: 285055  model H179 serial numbers: 114267, 114268, 114269,  114270, 114271, 114280, 114470.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. AZ, FL, GA, IL, IN, KY, MA, ME, MI, MN, NC, NE, NY, OH, PA, TN, TX, UT, VA, WI. OUS to include: Australia, Canada, Germany, Italy, Netherlands, Portugal, Slovenia, Spain.
  • 제품 설명
    Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • 제조사 주소
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA