Events

Alerta De Seguridad O Notificaciones De Seguridad para Dual Chamber Pacemakers

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 Medtronic Ltd.

¿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/2011/060
  • Fecha
    2011-06-02
  • 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-dual-chamber-pacemakers-confirm-actions-with-manufacturer-after-receipt-of-field-safety-notices
  • 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
    The manufacturer issued a Field Safety Notice (FSN) – Medtronic Reference: FA507 (675Kb) – for these devices on 4 April 2011, but has not had sufficient confirmation from users that they have received and acted on this information.A copy of the FSN is in the appendix of this Alert, and it is also available on the MHRA website.
  • Causa
    (medtronic ltd); manufacturer has not had sufficient confirmation from users that they have received and acted on field safety notice (reference: fa507). (mda/2011/060).
  • Acción
    Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.

Device

Dual Chamber Pacemakers
  • Modelo / Serial
  • Descripción del producto
    Dual Chamber Pacemakers.Medtronic models: Kappa 600, 700, 800 and 900; EnPulse; Adapta; Versa; Sensia; Relia.Vitatron models: E50A1, E60A1 and G70A1.
  • Manufacturer
    Medtronic Ltd

Manufacturer

Medtronic Ltd
  • Dirección del fabricante
    Lezlie Bridge Medtronic Ltd Building 9 Croxley Green Business Park Hatters Lane Watford WD18 8WW Tel: 07740 899 216 Fax: 01923 225 273Email: lezlie.j.bridge@medtronic.com
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA