BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 23402616 · Received October 28, 2025

    Report

    Report Number
    1644487-2025-10767
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 2, 2025
    Report Date
    February 25, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 CFR 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

    H3. DEVICE EVALUATED BY MFR? CODE 02 - PRODUCT ANALYSIS OF THE SUSPECT PRODUCT IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE SUSPECT GENERATOR. OTHER THAN THE NOTED EVENT (VBAT<EOS THRESHOLD), THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANT SURGERY THE GENERATOR WAS FIRST CHECKED IN PACKAGING AND AFTER BEING IMPLANTED THE BATTERY WAS OK. DURING THE FINAL SYSTEM DIAGNOSTIC TEST, THE BATTERY INDICATED EOS (END OF SERVICE): YES. IT WAS NOTED THAT NO ELECTROCAUTERY WAS USED DURING THE IMPLANT AND A NEW GENERATOR HAD TO BE USED INSTEAD. PER THE DECODER REVIEW, THE BATTERY VOLTAGE WENT FROM 3.156 V TO 1.916 V AND THEN STARTED BOUNCING BACK SLOWLY TO 1.963V. THE BATTERY VOLTAGE WAS NOTED TO BE 1.916, EOS=YES. HOWEVER, THE CHARGED CONSUMED WAS ONLY 0.517% MEANING 99.483% BATTERY SHOULD HAVE BEEN REMAINING AND NOT 0%. THIS BEHAVIOR OF THE BATTERY VOLTAGE IS INDICATIVE OF ASIC LATCH-UP CONDITION, WHERE THE GENERATOR MAY HAVE BEEN EXPOSED TO ELECTROMAGNETIC INDUCTION (EMI) OR ELECTROSTATIC DISCHARGE (ESD) TRANSIENTS LEADING TO PREMATURE BATTERY DEPLETION. THE SUSPECT GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE SUSPECT GENERATOR WAS RECEIVED, AND PRODUCT ANALYSIS IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2353165 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 8150 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Unknown