BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 300

    MDR report key: 21731759 · Received March 31, 2025

    Report

    Report Number
    1644487-2025-00355
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    December 9, 2024
    Report Date
    May 8, 2025
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 HAVE NOT 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

    F10: MEDICAL DEVICE CODE; CORRECTED INFORMATION, INITIAL REPORT: INADVERTENTLY USED A072201 INSTEAD OF A040101. H6: INVESTIGATION FINDINGS; CORRECTED INFORMATION, INITIAL REPORT: INADVERTENTLY USED C0203 INSTEAD OF C070603.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A NORMAL BATTERY REPLACEMENT, THE PATIENT WAS SEEN WITH HIGH IMPEDANCE. THE PATIENT UNDERWENT A FULL REVISION AT A LATER DATE. ABRADED INSULATION WHICH RESULTED IN THE LEAD WIRE BEING EXPOSED WAS IDENTIFIED DURING THE FULL REVISION SURGERY. THE SUSPECT PRODUCT HAS BEEN RECEIVED BY THE MANUFACTURER. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PRODUCT DEVICE HISTORY RECORD AND PRODUCT ANALYSIS WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933199 LEAD MODEL 300 LEAD LYJ CYBERONICS - HOUSTON 300-20 44270

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male