BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 23662899 · Received November 26, 2025

    Report

    Report Number
    1644487-2025-10896
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 27, 2025
    Report Date
    February 2, 2026
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750504
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6. ADVERSE EVENT PROBLEM CODES; CORRECTED INFORMATION; E011901 INADVERTENTLY LEFT OFF OF INITIAL REPORT DESPITE BEING KNOWN AT THE TIME OF SUBMISSION. H4. DEVICE MANUFACTURE DATE; CORRECTED INFORMATION; MANUFACTURE DATE INADVERTENTLY LEFT OFF OF INITIAL REPORT DESPITE BEING KNOWN AT THE TIME OF SUBMISSION. D4. LOT NUMBER; CORRECTED INFORMATION; LOT NUMBER INADVERTENTLY LEFT OFF OF INITIAL REPORT DESPITE BEING KNOWN AT THE TIME OF SUBMISSION.

    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

    IT WAS REPORTED THAT VNS THE PATIENT EXPERIENCED ASYSTOLE AND WAS BROUGHT BACK AFTER A SEIZURE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899471 PULSE GEN MODEL 1000 GENERATOR LYJ HOUSTON 1000 206303 05425025750504

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Life Threatening