Events

Implantable pulse generators (IPGs) neurostimulators 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/2011/079
  • 날짜
    2011-07-13
  • 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-pulse-generators-ipgs-neurostimulators-confirm-actions-from-field-safety-notice
  • 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
    Faulty battery components have resulted in some IPGs losing the ability to communicate with the programmer or recharge. In the cases reported, the duration between recharges became progressively shorter until the IPG failed to charge or there was a sudden loss of power, which resulted in the need for device replacement. The time from manufacture of affected devices to explant has so far ranged from eight months to two years.
  • 원인
    (st jude medical) manufacturer not received sufficient confirmation of action after a field safety notice was sent out on the faulty battery components that could result loss in ability to communicate with the programmer or recharge in some ipgs. (mda/2011/079).
  • 조치
    Read the manufacturer’s Field Safety Notice (FSN) (226Kb) Identify affected patients using the list of serial numbers within the FSN Review affected patients and advise them to contact their clinician immediately in the event of a sudden loss of device power Patients fitted with devices that are noted to have a shorter duration between recharges should be considered for a replacement device on an individual

Device

Implantable pulse generators (IPGs) neurostimulators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Implantable Pulse Generators (IPGs) – Neurostimulators. Eon Mini™ (Model 65-3788) and Brio™ (Model 65-6788).Manufactured by St Jude Medical.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • 제조사 주소
    Sean Hogarth St Jude Medical UK Ltd Capulet House Stratford Business and Technology Park Stratford Upon Avon CV37 7GX Tel: 01789 207 611 Fax: 01789 207 601Email: SHogarth@SJM.com
  • 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