Events

Implantable cardioverter defibrillators (ICDs) 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 St Jude Medical 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/2005/045
  • 날짜
    2005-07-25
  • 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-implantable-cardioverter-defibrillators-icds-ensure-you-have-updated-software-for-models-3510-and-3510-icd-programmers
  • 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
    St Jude Medical has informed the MHRA and all customers (Dear Doctor Letter dated 14 June 2005) that the above Atlas and Epic ICD models have the potential to experience either or both of the following problems:
  • 원인
    (st jude medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. (mda/2005/045).
  • 조치
    Verify that all St Jude Medical Model 3510 and 3510+ ICD programmers have been upgraded by St Jude Medical with software version 4.8.5 (or higher) by 27 July 2005. Identify all patients implanted with the affected Epic or Atlas ICDs (serial number below 225000). Ensure that identified patients are followed up (including interrogation of ICDs using a St Jude Medical upgraded programmer Model 3510 or 3510+):* by the end of September 2005, where the affected implanted devices are programmed at higher electrical current settings by the end of December 2005, for all other affected implanted devices. Report any instances of device failure to MHRA and St Jude Medical. Report any explants to the National Pacing and ICD database.

Device

Implantable cardioverter defibrillators (ICDs)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    St Jude Medical implantable cardioverter defibrillators (ICDs):Atlas DR model: V-242     Atlas Plus DR/VR/HF models: V-243, V-193, V-193C, V-340, V-341, V-343     Epic DR/HF models: V-233, V-337, V-338     Epic Plus DR/VR/HF models: V-236, V-239, V-196, V-239T, V-196T, V-350
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    MHRA