Events

Accent DR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St Jude Medical CRMD 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
    60134
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0429-2012
  • 사례 시작날짜
    2011-09-23
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104490
  • 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
    St. jude medical has received reports of out of range pacing lead impedance (pli) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. the out of range readings are concluded as false.
  • 조치
    The firm, St. Jude Medical, sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated September 22, 2011 to its customers by FedEx priority overnight service for planned receipt on September 23, 2011. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed that in order to prevent a false reading, a new programmer software version (12.1.0.1) is available. This software when used to interrogate an Accent DR or Anthem CRT-P pacemaker will eliminate the potential for this anomaly to occur. The onetime upgrade is performed automatically on affected devices and will not change the operation of the implanted device. A St. Jude Medical Sales Representative will assist the customers in loading the new programmer software onto their Merlin programmer. Customers with questions or concerns, can contact their local St. Jude Medical representative or their Technical services department at (800) 722-3774.

Device

Accent DR
  • 모델명 / 제조번호(시리얼번호)
    PM2110, 2112, 2210, 2212 (Accent DR)  All lots and serial numbers
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Asia Pacific, Belgium, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latin America, Lebanon, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, UK, and U.A.E.
  • 제품 설명
    Implantable Pacemaker Accent DR models PM2110 and PM2210 || St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • 제조사 주소
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA