BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 22123556 · Received June 2, 2025

    Report

    Report Number
    1644487-2025-10191
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    October 1, 2022
    Report Date
    December 14, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Additional Manufacturer Narrative · 0

    B1. TYPE OF REPORT; CORRECTED INFORMATION, INITIAL MDR SELECTED INCORRECT OPTION B2. OUTCOMES ATTRIBUTED TO ADVERSE EVENT; CORRECTED INFORMATION, INITIAL MDR SELECTED INCORRECT OPTION. H1. TYPE OF REPORTABLE EVENT; CORRECTED INFORMATION, INITIAL MDR SELECTED INCORRECT OPTION.

    Additional Manufacturer Narrative · 0

    D4, DEVICE INFORMATION, CORRECTED DATA: INITIAL REPORT INADVERTENTLY SUBMITTED WITHOUT DEVICE LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INCREASED SEIZURES. THE PATIENT'S MOTHER REPORTS THAT THE INCREASED SEIZURES COME IN WAVES (SPIKE IN SEIZURES THEN FALL BACK TO BASELINE) SINCE (B)(6) 2022. STARTING AT THE END OF (B)(6) 2025, THE PATIENT HAS HAD A STEADY INCREASE OF SEIZURES. IT WAS FURTHER REPORTED THAT THE PATIENT'S GENERATOR WAS REPLACED DUE TO BATTERY DEPLETION. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PRELIMINARY DETAILS INDICATE THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392022 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205264 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention