Events

Alerta De Seguridad O Notificaciones De Seguridad para Implantable pulse generators (IPGs) neurostimulators

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por St Jude Medical.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2011/079
  • Fecha
    2011-07-13
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/medical-device-alert-implantable-pulse-generators-ipgs-neurostimulators-confirm-actions-from-field-safety-notice
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    (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).
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    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
  • Dirección del fabricante
    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
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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