BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 18606249 · Received January 30, 2024

    Report

    Report Number
    1644487-2024-00083
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    October 1, 2023
    Report Date
    April 25, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    NEW INFORMATION WAS RECEIVED REPORTING THE EXPLANTED DEVICE WAS DISCARDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE PATIENT'S GENERATOR WAS LATER EXPLANTED DUE TO BATTERY DEPLETION. THE DEVICE HAS NOT BEEN RETURNED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING MORE DROP SEIZURES AND INCREASED BITING MORE RECENTLY. THE MOTHER THINKS THE INCREASED SEIZURES COULD BE RELATED TO LOW BATTERY AND THE INCREASED BITING RELATED TO SENSORY ISSUES, HOWEVER THIS WAS NOT CONFIRMED BY THE PHYSICIAN TO DATE. THE PHYSICIAN HAS INCREASED MEDICATION FOR THESE REPORTED EVENTS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551885 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 204470 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Required Intervention