Events

Alerta De Seguridad O Notificaciones De Seguridad para Implantable cardioverter defibrillators (ICDs)

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/2005/045
  • Fecha
    2005-07-25
  • 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-cardioverter-defibrillators-icds-ensure-you-have-updated-software-for-models-3510-and-3510-icd-programmers
  • 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
    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:
  • Causa
    (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).
  • Acción
    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)
  • Modelo / Serial
  • Descripción del producto
    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
  • 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