Events

Device Recall Sigma Pacemaker 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc. Cardiac Rhythm Managment 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
    34093
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0535-06
  • 사례 시작날짜
    2005-11-29
  • 사례 출판 날짜
    2006-02-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-01-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43101
  • 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
    An issue exists with a specific subset of sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. this failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. there have been no reported patient injuries or deaths due to this issue.
  • 조치
    Press Release was issued 11/29/05. Hospital/physician letters sent via registered mail on 11/29/05 for delivery on 12/01/05. Unimplanted devices are being retrieved. The Physician letter describes the issue, root cause, the probability of reoccurrence and provides recommendations. A list of affected serial numbers that the physician is following or has implanted is attached to the letter. The letter also provides medtronic's website in which regular updates on the ongoing actual performance are listed in their Product Performance Report. Medtronic is providing a replacement device should the Physician and patient elect to replace the affected implanted device.

Device

Device Recall Sigma Pacemaker
  • 모델명 / 제조번호(시리얼번호)
    Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SDR203: serial no. PJD183978h - PJD184012h, PJD186200H - PJD186279H, PJD187571H - PJD187669H, PJD193734H, PJD195394H - PJD195470H, PJD442170H, PJD445718H - PJD452929H, PJD674175S - PJD680868S, PJD685590S, PJD689228S, PJD691226S, PJD731742S - PJD739835S. Model SDR 303: serial no. PJD182452H - PJD199059H, PJD205280H, PJD440288H - PJD451956H, PJD674216S - PJD691410S, PJD730124S - PJD746998S. Model SDR 306: serial no. JE120662H - PJE120706H, PJE620733S - PJE621387S.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
  • 제품 설명
    Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Fridley MN 55432
  • Source
    USFDA