BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 23503590 · Received November 7, 2025

    Report

    Report Number
    1644487-2025-10805
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 22, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6, TYPE OF INVESTIGATION. INITIAL REPORT INADVERTENTLY USED B17 INSTEAD OF B20. H6, INVESTIGATION FINDINGS. INITIAL REPORT INADVERTENTLY USED C20 INSTEAD OF C0203. H6, MEDICAL DEVICE PROBLEM CODE. INITIAL REPORT INADVERTENTLY USED A040101 INSTEAD OF A072201.

    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 VIA PRODUCT ANALYSIS OF THE GENERATOR. THE ANALYSIS REVEALED THAT THE GENERATOR FUNCTION AS EXPECTED ALONG WITH SOME NEW HIGH IMPEDANCE DATA. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    A CALL WAS RECEIVED FROM AN OPERATING ROOM STAFF MEMBER REPORTING HIGH IMPEDANCE READING DURING A PROCEDURE. ALL STANDARD TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING VERIFYING LEAD PLACEMENT, CLEANING, CHECKING FOR TISSUE INTERFERENCE, FLUSHING THE GENERATOR, CONFIRMING CONNECTIONS, AND RUNNING SYSTEM DIAGNOSTICS MULTIPLE TIMES. IMPEDANCE VALUES RANGED FROM 5300 TO 7900 OHMS. A GENERATOR DIAGNOSTIC TEST SHOWED 4000 OHMS, WHICH WAS LATER DEEMED WITHIN NORMAL RANGE. A BACKUP GENERATOR WAS IMPLANTED, SHOWING IMPEDANCE AROUND 4000 OHMS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874032 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 206586 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female