BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 21389438 · Received February 14, 2025

    Report

    Report Number
    1644487-2025-00163
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    December 10, 2024
    Report Date
    February 14, 2025
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANT, THE ANCHOR TETHER HELIX WAS NOT FULLY SEPARATED AND IT COULD NOT PROPERLY STRETCH TO COIL AROUND NERVE. PER THE REPORT, THE TOP COIL OF THE ANCHOR TETHER'S HELIX WAS SLIGHTLY ADHERED TO THE CENTER COIL, BUT THE SURGEON WAS ABLE TO SEPARATE THE TETHER HELIX WITH MANIPULATION, AND THE LEAD WAS SUCCESSFULLY IMPLANTED, WITH THE LEAD LOOKING NORMAL. A REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THE LEAD PASSED QUALITY CONTROL INSPECTION PRIOR TO DISTRIBUTION. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152105 LEAD MODEL 304 LEAD LYJ CYBERONICS - HOUSTON 304-20 7922

    Patients

    Seq Age Sex Outcome Treatment
    1 31 MO Male