BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 23633915 · Received November 24, 2025

    Report

    Report Number
    1644487-2025-10873
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    January 1, 2020
    Report Date
    February 9, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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

    FURTHER FOLLOW UP FROM THE PATIENT'S PROVIDER REPORTED THAT THE PATIENT EXPERIENCED GRAND MAL SEIZURES PRIOR TO VNS. IT WAS ALSO NOTED THAT THE PATIENT'S GRAND MAL SEIZURES WERE NOT DUE TO VNS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS VNS BATTERY HAD DEPLETED IN 2020 BUT BEFORE THAT, THE PATIENT WAS CONSTANTLY EXPERIENCING GRAND MAL SEIZURES. THE PATIENT REPORTED THAT THEY COMPLETELY STOPPED EXPERIENCING SEIZURES IN (B)(6) 2025. PATIENT HAS BEEN REFERRED FOR VNS BATTERY REPLACEMENT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361601 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 204063 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other