BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 22757954 · Received August 8, 2025

    Report

    Report Number
    1644487-2025-10487
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 16, 2025
    Report Date
    January 27, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    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.

    Additional Manufacturer Narrative · 0

    H6 TYPE OF INVESTIGATION. INITIAL REPORT INADVERTENTLY DID NOT CODE B13.

    Additional Manufacturer Narrative · 0

    H6: MEDICAL DEVICE PROBLEM CODE, SUPPLEMENTAL REPORT SHOULD HAVE UPDATED THE CODE FROM A040101 TO A072201. H6: INVESTIGATION FINDINGS, SUPPLEMENTAL REPORT SHOULD HAVE USED C0203 INSTEAD OF C19. H6: INVESTIGATION CONCLUSION, SUPPLEMENTAL REPORT SHOULD HAVE USED D1401 INSTEAD OF D1402.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE DURING CLINIC VISIT. THE PATIENT HAS BEEN REFERRED FOR REPLACEMENT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. PATIENT WAS SEEN BY SURGEON. LEAD IMPEDANCE WAS SEEN TO BE NORMAL. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522339 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 HP 203061 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female