BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 22771388 · Received August 11, 2025

    Report

    Report Number
    1644487-2025-10490
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 17, 2025
    Report Date
    September 3, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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 HAVE NOT 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

    IMPLANT CARD RECEIVED NOTING THAT THE PATIENT UNDERWENT SURGERY AND HAD THEIR GENERATOR REPLACED. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC AND WHEN TRYING TO INTERROGATE THEIR DEVICE, ERROR CODE 128 WAS OBSERVED. THE FOLLOWING TROUBLESHOOTING STEPS WERE TRIED TO NO AVAIL: RE-INSERTING THE WAND BATTERIES, HARD WIRED CONNECTION BETWEEN THE WAND AND TABLET, CONFIRMED WAND PLACEMENT AND REMOVED SOURCES OF EMI AND A GENERATOR RESET. IT WAS CONFIRMED THAT THE PATIENT IS ABLE TO STILL FEEL STIMULATION WHEN USING THE MAGNET. IT WAS ALSO REPORTED THAT 5 DIFFERENT PROGRAMMERS WERE USED AND THE PATIENT STILL COULD NOT BE INTERROGATED. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EVENTS ASSOCIATED WITH THE LOSS OF STIMULATION AND NOTING UNUSUAL HAS OCCURRED FOR THE PATIENT. THE GENERATOR CAN BE EASILY PALPATED UNDER THE SKIN. THE DEVICE HISTORY RECORDS FOR THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED ALL SPECIFICATIONS, INCLUDING QUALITY CONTROL INSPECTION, AND SHOWED NO NON-CONFORMITIES, PRIOR TO ITS RELEASE INTO THE FIELD FOR DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914910 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 871 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male