BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 303

    MDR report key: 23748057 · Received December 8, 2025

    Report

    Report Number
    1644487-2025-10930
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    April 25, 2025
    Report Date
    December 31, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    UDI-DI
    00542502575011
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2: PRODUCT CODE: INITIAL REPORT INADVERTENTLY USED LYJ INSTEAD OF MUZ. G2: REPORT SOURCE: INITIAL REPORT INADVERTENTLY DID NOT SELECT STUDY. H6: HEALTH EFFECT: INITIAL REPORT INADVERTENTLY CODED F1205 INSTEAD OF F1202. B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT: INITIAL REPORT INADVERTENTLY SELECTS OTHER RATHER THAN DISABILITY.

    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 THE PATIENT WAS EXPERIENCING (RECURRENT NERVE PALSY). THE PALSY WAS NOTED TO HAVE A CAUSAL RELATIONSHIP WITH IMPLANT PROCEDURE. THESE EVENTS WERE NOTED TO BE RECOVERED AND RESOLVED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858366 LEAD MODEL 303 LEAD MUZ LIVANOVA USA, INC. 303-20 841 00542502575011

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Disability| O