Events

Field Safety Notices about REPLY, ESPRIT, KORA and FACIL1 pacemakers

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
    2016-09-29
  • 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
    This letter provides information about a new software version that improves the accuracy of the estimated residual longevity calculated and displayed by the programmer during a follow-up exam of patients implanted with livanova pacemakers. the overall longevity of these devices is not affected. when an implanted device approaches the recommended replacement time (rrt), the previous, less accurate, residual longevity estimate provided by the programmer at follow-up could result in reaching rrt between two follow-up visits. no permanent injury or death has occurred as a result of this inaccuracy. .

Device

REPLY, ESPRIT, KORA and FACIL1 pacemakers

Manufacturer

LivaNova PLC