Events

Notificaciones De Seguridad De Campo acerca de REPLY, ESPRIT, KORA and FACIL1 pacemakers

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por LivaNova PLC.

¿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
    Field Safety Notice
  • Fecha
    2016-09-29
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    This letter provides information about a new software version that improves the accuracy of the estimated residual longevity calculated and displayed by the programmer during a follow-up exam of patients implanted with livanova pacemakers. the overall longevity of these devices is not affected. when an implanted device approaches the recommended replacement time (rrt), the previous, less accurate, residual longevity estimate provided by the programmer at follow-up could result in reaching rrt between two follow-up visits. no permanent injury or death has occurred as a result of this inaccuracy. .

Device

REPLY, ESPRIT, KORA and FACIL1 pacemakers

Manufacturer

LivaNova PLC