Events

Device Recall PULSAR and PULSAR MAX pacemaker 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
    32681
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1034-05
  • 사례 시작날짜
    2005-07-18
  • 사례 출판 날짜
    2005-07-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-01-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40550
  • 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 Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
  • 원인
    A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
  • 조치
    INITIAL RECALL Urgent medical Device Safety Information & Corrective Action letter dated 07/18/05 was issued to physicians listing clinical Implications and patient management recommendations. EXPANDED RECALL Press was issued January 23, 2006. Urgent Medical Device Safety Information & Corrective Action letter, dated 01/21/06, was issued to physicians listing a summary of previous communication to physicians, advisory population update, and information relative to a second population of devices manufactured between October 19, 1998 and December 5, 2000. This letter gives the observed rate of occurrence, clinical implications, projected rate of occurrence and recommendations.

Device

Device Recall PULSAR and PULSAR MAX pacemaker
  • 모델명 / 제조번호(시리얼번호)
    Affected devices may be contained in the following serial number ranges.  Model 470: INITIAL RECALL serial numbers 101150 thru 101894. EXPANDED RECALL serial numbers 101188 thru 102201. Model 870: INITIAL RECALL serial numbers 200201 thru 201205. EXPANDED RECALL serial numbers 200125, 200127, 200184, 200190, 200372, 200565, 201129, 201461, 201462, 201499, 201613. Model 970: INITIAL RECALL serial numbers 300808 thru 301676. EXPANDED RECALL serial numbers 300555 thru 301709 Model 972: INITIAL RECALL serial numbers 452959 thru 454562. EXPANDED RECALL serial numbers 401085, 401112, 452941, 453275, 453278, 453287, 453333, 453357,  453375, 453479, 453722, 453737, 454073  Model 1170: INITIAL RECALL serial numbers 100610 thru 103665. EXPANDED RECALL serial numbers 100213 thru 106149. Model 1171: INITIAL RECALL serial numbers 300733 thru 302575. EXPANDED RECALL serial numbers 300378 thru 303251, 594438, 594439, 594441, 594442. Model 1172: INITIAL RECALL serial numbers 594273 thru 594437. EXPANDED RECALL serial numbers 594293 thru 594417. Model 1270: INITIAL RECALL serial numbers 595951 thru 608303. EXPANDED RECALL serial numbers 500254 thru 619402. Model 1272: INITIAL RECALL serial numbers 600250 thru 600749. EXPANDED RECALL serial numbers 600265 thru 600823.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cyprus, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guyana, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Singapore,Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan ROC, Turkey, United Kingdom, Uruguay and Venezuela. EXPANDED RECALL additional countries include: China, Croatia, Korea. Lithuania, Madagascar, Maldives, Malta, Monaco, Nepal and Thailand.
  • 제품 설명
    PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. PULSAR and PULSAR MAX pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, many offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available with the adaptive-rate models; these adapt the pacing rate to the patient's changing metabolic demand.
  • Manufacturer
    Guidant Corporation

Manufacturer

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