Events

Pacemaker 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Sorin CRM 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 연번
    MDA/2011/056
  • 날짜
    2011-05-25
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-pacemaker-reply-and-esprit-models-interrogated-with-programmer-containing-software-version-2-24-software-anomaly
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • 데이터 추가 비고
    The manufacturer has issued a Field Safety Notice (see appendix) following a programmer software anomaly that could lead to:cardiac instability during surgery when a magnet is applied; or
    unnecessary explant due to inconsistent battery information.This software anomaly sets the magnet rate at 30 beats per minute following interrogation by a programmer with the 2.24 software version.
  • 원인
    (sorin crm) field safety notice published after a programmer software anomaly was found that could lead to cardiac instability or unnecessary explant due to inconsistent battery information. (mda/2011/056).
  • 조치
    Do not use a programmer with 2.24 software version. Ensure that the manufacturer has provided you with an alternative software version, 2.26 or higher (or 2.22 if necessary). Identify all patients implanted with Reply or Esprit pacemakers that have previously been interrogated with the 2.24 programmer software version: arrange for follow-up of affected patients in order to interrogate with the alternative software version to correct the magnet rate within 3 months consider the need to review end-of-life explant decisions made following interrogation with 2.24 version.For patients undergoing surgery:Identify affected patients preoperatively interrogate with the alternative software alternatively do not use a magnet in affected patients. If a magnet is used and the heart rate drops to 30 beats per minute, remove the magnet.

Device

Pacemaker
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Pacemaker.Reply and Esprit models that have been interrogated with programmer containing software version 2.24.Manufactured by Sorin CRM.Model   Serial number configuration (where x is any alphanumeric character)         Reply DR   8xxZKxxx   9xxZKxxx   0xxZKxxx Reply D   8xxZLxxx   9xxZLxxx   0xxZLxxx Reply VDR   8xxZMxxx   9xxZMxxx   0xxZMxxx Reply SR   8xxZNxxx   9xxZNxxx   0xxZNxxx Esprit DR   8xxZPxxx   9xxZPxxx   0xxZPxxx Esprit D   8xxZRxxx   9xxZRxxx   0xxZRxxx Esprit SR   8xxZSxxx   9xxZSxxx   0xxZSxxx Esprit S   8xxZTxxx   9xxZTxxx   0xxZTxxx
  • Manufacturer
    Sorin CRM

Manufacturer

Sorin CRM
  • 제조사 주소
    Ms Chantal Cadiou Sorin Group France Tel: +33 146013687 Fax: +33 149655451Email: Chantal.cadiou@sorin.com
  • 제조사 모회사 (2017)
    LivaNova PLC
  • Source
    MHRA