Events

INSIGNIA Entra and NEXUS Entra 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
    33491
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0187-06
  • 사례 시작날짜
    2005-09-22
  • 사례 출판 날짜
    2005-09-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-12-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41956
  • 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 Pacemaker Pulse-Generator - Product Code DXY
  • 원인
    A failure mode occurring at a low rate, has been identified within the insignia and nexus families of implantable pacemakers. device behaviors which may be observed include: intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
  • 조치
    Important Medical Device Safety Information & Corrective Action , dated 09/22/05 was sent to all affected physicians. This letter explained the failure mode, what devices are affected and gave recommendations. A press release was issued on 09/22/05.

Device

INSIGNIA Entra and NEXUS Entra
  • 모델명 / 제조번호(시리얼번호)
    Affected devices may be found in the following serial number ranges. INSIGNIA Entra SSI (model 0484) serial no. 100879 - 115237; (model 0485) serial no. 100088 - 100104; NEXUS Entra SSI (model 1326) serial no. 100122 - 100175. INSIGNIA Entra DDD (model 0985) serial no. 100059 - 100089; (model 0986) serial no. 100600 - 104439; NEXUS Entra DDD (model 1426) serial no. 100032 - 100091. INSIGNIA Entra SR (model 1195) serial no. 100739 - 101623; (model 1198) serial no. 102498 - 117468; NEXUS Entra SR (model 1398) serial no. 100067 - 100120. INSIGNIA Entra DR (model 1294) serial no. 101132 - 107445 & 292190; (model 1295) serial no. 100503 - 102668; (model 1296) serial no. 101519 - 153064; NEXUS Entra DR (model 1494) serial no. 100028 & 100029.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide and Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Polynesia, Portugal, Qatar, Reunion, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela
  • 제품 설명
    Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • 제조사 주소
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5798
  • Source
    USFDA