BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 22817670 · Received August 15, 2025

    Report

    Report Number
    1644487-2025-10504
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 16, 2025
    Report Date
    October 25, 2025
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D5, OPERATOR OF DEVICE, CORRECTED DATA: INITIAL REPORT SHOULD HAVE BEEN MARKED WITH HEALTH PROFESSIONAL AS OPERATOR OF DEVICE.

    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 HIGH IMPEDANCE WAS SEEN FOLLOWING A BATTERY CHANGE. PRE-OPERATIVE IMPEDANCE WAS WITHIN NORMAL LIMITS, BUT WITH NEW GENERATOR, HIGH IMPEDANCE WAS SEEN IN THE OPERATING THEATER. THE PATIENT WAS CLOSED AND SENT FOR X-RAYS. PHYSICIAN ASSESSMENT OF X-RAYS TAKEN STATES "VNS IN SITU. NO LEAD DISCONTINUITY." X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER. SURGERY WAS PLANNED ON (B)(6) TO CHECK THE GENERATOR-LEAD CONNECTION. ON THAT DATE, THE PATIENT WAS BROUGHT BACK INTO THEATRE AND THE LEAD PIN WAS REMOVED AND REATTACHED. SYSTEM DIAGNOSTICS WERE PERFORMED AND FOUND TO BE WITHIN THE NORMAL RANGE, SO THE CONCLUSION DRAWN WAS THAT THE SURGEON HAD NOT FULLY INSERTED THE PIN IN THE PREVIOUS SURGERY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO ADDITIONAL KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2787889 PULSE GEN MODEL 1000 GENERATOR LYJ HOUSTON 1000 206490 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male