Events

Avis De Sécurité sur Ovatio, Paradym, Paradym RF, Paradym 2 and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

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
  • Date
    2017-04-11
  • 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
    In the event of a right ventricular lead issue (e.G. broken or disconnected lead), recurrent shock capacitor charging due to ventricular oversensing may result in depletion of the icd or crt-d battery. because the battery status is not updated for a 24-hour period following a charge, battery depletion may remain undetectable during the 24 hours following the last charge. recurrent charging will stop either after deactivation of the shock therapies, or when the oversensing stops, such as in the case of a lead revision. .

Device

Ovatio, Paradym, Paradym RF, Paradym 2 and Intensia Implantable Cardioverter Defibrillators (ICDs...

Manufacturer

LivaNova PLC