Events

Guidant CONTAK RENEWAL® (model H135) and CONTAK RENEWAL® 2 (model H155) 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 manufacturer #17429 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 ID
    MDA/2005/038
  • 사례 연번
    CON1004071
  • 날짜
    2005-06-27
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON1004071
  • 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
  • 원인
    Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock. guidant has identified the potential for loss of therapy in all contak renewal® (model h135) and contak renewal® 2 (model h155) cardiac resynchronization therapy defibrillators (crt-ds) manufactured on or before 26 august 2004. on delivery of defibrillation therapy the high voltage pulse may discharge (or arc) between the high voltage defibrillation output wire and titanium casing. the resulting high current may damage the crt-d electronics causing one or more of the following: loss of arrhythmia detection/ therapy delivery bradycardia pacing output telemetry/ programming/ interrogation partial delivery of intended shock energy. a red warning screen indicating malfunction a yellow warning screen indicating 'out of range' shocking impedance.
  • 조치
    See actions on page 3. Ensure that follow-up intervals are no greater than three months; consider immediate review of all patients whose last follow-up was more than three months ago. Replace all devices in which high voltage therapy has been compromised. Remind patients to contact their follow-up centre immediately, if they hear audible bleeping from their device, experience shock therapy and/or arrhythmias/resumption of symptoms which remain uncorrected by the device. Report of instances of device failure to MHRA and Guidant. Report explants to the National Pacing and ICD database (see contacts). ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines. Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf

Device

Guidant CONTAK RENEWAL® (model H135) and CONTAK RENEWAL® 2 (model H155)
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 제품 설명
    Guidant CONTAK RENEWAL® (model H135) and CONTAK RENEWAL® 2 (model H155) implantable cardiac resynchronization therapy defibrillators (CRT-Ds).
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429