Events

Device Recall Boston Scientific COGNIS CRTD 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
    52809
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1932-2009
  • 사례 시작날짜
    2009-07-20
  • 사례 출판 날짜
    2009-08-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84049
  • 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
    Cardiac Resynchronization Therapy Defibrillator - Product Code LWP
  • 원인
    Boston scientific cardiac rhythm management retrieved devices that could be subject to a potential for acute non-secure lead connections when implanted. nonsecure lead connections can manifest as high impedance, or lead electrogram artifacts resulting in oversensing and/or inappropriate delivery of therapy.
  • 조치
    Boston Scientific Corporation field personnel began retrieving devices containing the original set screw system on Friday, July 17, 2009. If needed a letter, dated 07/17/2009 was left with the hospital administrator letting them know that product has been collected for return to Boston Scientific Corporation. Replacement devices will be provided at no charge. If the field personnel was unable to contact the hospital in the time provided, a notification letter dated July 22, 2009 was sent via Federal Express to the hospital. This letter was directed to the EP Catheter Lab Manager with a cc to the Hospital Risk Manager, Hospital Administrator and Purchasing and Central Supply. The letter asked that the affected devices not be implanted and to contact their local representative for pick-up and return. The firm will replace the affected devices. Please direct questions to your local Sales representative or Boston Scientific Corporation CRM Technical Services by calling 1-800-227-3422.

Device

Device Recall Boston Scientific COGNIS CRTD
  • 모델명 / 제조번호(시리얼번호)
    Model N118, Serial numbers: 559134, 559655, 560551, 561872, 561997, 562290, 562354, 562357, 563022, 563129, 564231, 564257, 564276 and 564489 and  Model N119, Serial numbers: 002009, 005588, 005947, 006015, 008336, 008383, 011748, 016012, 016410, 018621, 019026, 019284, 024632, 024670, 024705, 025094, 025446, 026128, 026211, 026713, 026935, 028047, 032967, 033881, 035717, 035791, 035824, 037277, 044056, 046565 and 046574.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    U.S. Distribution only (states of AZ, CA, CT, FL, GA, IA, IL, KY, MD, MO, NH, NJ, NY, OH, PA, SC, TN, TX, WI, and Washington D.C.) and Puerto Rico.
  • 제품 설명
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. || The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

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