BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 23512612 · Received November 10, 2025

    Report

    Report Number
    1644487-2025-10808
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    June 1, 2025
    Report Date
    March 6, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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

    INTERNAL DATA FROM THE GENERATOR WAS RECEIVED AND REVIEWED. IT IS KNOWN FOR M1000 GENERATORS WITH SERIAL NUMBER LESS THAN 400,000 UPON RESET, AFTER RE-ENABLING THE THERAPY, AUTOSTIM IS NOT RE-ENABLED AND THE USER NEEDS TO ENABLE THE AUTOSTIM MANUALLY. HENCE THE REPORTED COMPLAINT OF AUTOSTIM DISABLING. BASED ON THE DATA, THE UPTIME WAS REPORTED TO BE 4/11/25 9:03 AM, WHICH IS ~5 MINS BEFORE THE INTERROGATION TIME. IT IS SUSPECTED THAT THERE WAS USAGE OF ESD OR EMI OR ELECTROCAUTERY TOOL WHICH CAUSED THE LATCHING UP ASIC IN TURN RAPIDLY DEPLETING THE BATTERY, REPORTING ERROR CODE 14.

    Description of Event or Problem · 0

    THE DATE OF EXPLANT WAS REPORTED. IT WAS NOTED THAT SUSPECT PRODUCT WAS DISCARDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S SETTINGS WERE FOUND TO HAVE BEEN SPONTANEOUSLY CHANGED PRIOR TO THE PATIENT UNDERGOING A BATTERY REPLACEMENT. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE EXPLANTED GENERATOR WAS DISCARDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927359 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205511 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown