Events

Notificaciones De Seguridad De Campo acerca de PLATINIUM

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
  • 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
    Potential programmer screen freeze during a 30hz pacing burst launched using rf telemetry as of june 30, 2016, livanova received four (4) reports (i.E. 0.087%) of programmer screen freeze during 30hz pacing while the test was launched using rf telemetry. the space bar of the programmer keyboard, as well as the buttons on the programmer screen remained unresponsive (buttons grayed out) during the delivery of the 30hz burst, making it impossible to stop the test before the end of the programmed burst duration2. if ventricular fibrillation is effectively induced, and the user wants to prematurely interrupt the 30hz pacing, there can be a delay in the delivery of the shock therapy which may prolong the syncope. however, the shock therapy will in all cases be effectively delivered in accordance with the induction sequence that was initially programmed: at the end of the programmed 30hz burst duration, antiarrhythmia functions are reactivated (arrhythmia detection algorithms, charging and shock therapy). this issue was only encountered during implantation procedures. .

Device

PLATINIUM

Manufacturer

LivaNova PLC