Events

Avis De Sécurité sur PLATINIUM

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par LivaNova PLC.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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