Events

Alerta De Seguridad O Notificaciones De Seguridad para Implantable cardioverter defibrillator (ICD)

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 Sorin CRM.

¿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/2011/073
  • Fecha
    2011-06-29
  • 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-defibrillator-icd-risks-with-pacing-inhibition
  • 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
    Risk of bradycardia / syncope due to pacing inhibition. Potential for pacing inhibition associated with ventricular oversensing if the follow-up monitoring feature, PhD, is programmed ON and the device is connected to high polarisation defibrillation leads. The manufacturer issued a Field Safety Notice (FSN) on 27 April 2011.
  • Causa
    (sorin crm) pacing inhibition causes risk of bradycardia / syncope; also potential association between pacing inhibition and ventricular oversensing if 'phd' is 'on' and the device is connected to high polarisation defibrillation leads. (mda/2011/073).
  • Acción
    Identify patients implanted with a Paradym ICD and for those patients known to be pacemaker dependent arrange follow-up within 1 month, in order to turn OFF the PhD feature. for all other affected patients, arrange for follow-up within 3 months in order to turn OFF the PhD feature. Put systems in place to ensure that the PhD feature is switched off at the end of every programming session until the programmer software upgrade has been implemented Note: The PhD feature is automatically activated when the shock therapy is switched on. Put systems in place to ensure that the PhD feature is switched OFF in newly implanted Paradym ICDs.

Device

Implantable cardioverter defibrillator (ICD)
  • Modelo / Serial
  • Descripción del producto
    Implantable cardioverter defibrillator (ICD) manufactured by Sorin CRM.Paradym, model numbers: VR 8250, DR 8550, CRT-D 8750 and 8770, VR 9250, DR 9550, CRT-D 9750 and 9770.
  • Manufacturer
    Sorin CRM

Manufacturer

Sorin CRM
  • Dirección del fabricante
    Ms Chantal Cadiou Sorin Group France Tel: 0033 146013687 Fax: 0033 149655451Email: Chantal.cadiou@sorin.com
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    MHRA