Events

Field Safety Notices about Ovatio, Paradym, Paradym RF, Paradym 2 and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by LivaNova PLC.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-04-11
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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