Events

Field Safety Notices about PLATINIUM

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
  • 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
    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