BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 23796208 · Received December 12, 2025

    Report

    Report Number
    1644487-2025-10950
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 19, 2025
    Report Date
    March 27, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS OF SUSPECT PRODUCT IN UNDER WAY.

    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

    ADDITIONAL INFORMATION RECEIVED. PRODUCT ANALYSIS WAS COMPLETED AND REVIEWED. THE REVIEW INDICATED THAT THE DEVICE WAS STRUCK BY ELECTROCAUTERY AND RETURN, CAUSED THE PREMATURE END OF LIFE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. THE SUSPECTED DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER. HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-OP, A NEW M106 WAS INTERROGATED TO APPLY THE PATIENT INITIALS, AND THE SESSION WAS ENDED. THE GENERATOR CURRENTLY IMPLANTED IN THE PATIENT ALSO HAD SYSTEM DIAGNOSTICS RUN TO CONFIRM LEAD INTEGRITY. AS THE NEW GENERATOR WAS TRANSFERRED INTO THE STERILE FIELD, THE SURGEON INSERTED THE PINS AS NORMAL AND WHEN SYSTEM DIAGNOSTICS WERE PERFORMED, 2 BOXES POPPED UP STATING "GENERATOR BATTERY EOS" AND "GENERATOR DISABLED ERROR CODE 8". AS FOUND DURING SURGERY, THE SURGERY PROCEEDED WITH OPENING AND USING A DIFFERENT GENERATOR TO IMPLANT IN PATIENT DUE TO NOT LOCATING A REASON IN THE MANUAL FOR DISABLEMENT. NEW OPENED GENERATOR INSERTED AND TESTED, AND PATIENT SURGERY WAS COMPLETED. AFTER SURGERY, REP ATTEMPTED SAME PROCESS AND RECEIVED YELLOW WARNING MESSAGE OF "THERAPY DISABLED - ERROR CODE 8". REP STATES THE GENERATOR IS AVAILABLE FOR RETURN. THE DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2770798 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 206523 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male