BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 20544831 · Received October 28, 2024

    Report

    Report Number
    1644487-2024-01353
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 1, 2024
    Report Date
    March 6, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 MEDICAL DEVICE CODE, CORRECTED DATA: A180130 AND A040507 WERE INCORRECTLY INCLUDED IN SUPPLEMENTAL #1.

    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 WHEN THE SURGEON WENT TO REPLACE THE PATIENT'S LEAD, THE DEVICE LOOKED UNUSUAL. IT WAS NOTED THAT THE METAL CONTACTS OF BOTH ELECTRODE COILS WERE SERPENTINE-LIKE WINDING AROUND THEMSELVES RATHER THAN ON THE PATIENT'S VAGUS NERVE. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE REASON FOR THE EXPLANT WAS DUE TO HIGH IMPEDANCE. IT WAS DURING THIS EXPLANT PROCEDURE THAT THE DAMAGED ELECTRODE WAS NOTICED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE SUSPECT DEVICE. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE EXPLANTED LEAD WAS LATER RECEIVED INTO PRODUCT ANALYSIS. ANALYSIS WAS COMPLETED ON THE LEAD. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020907 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 300425 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male