BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 18867034 · Received March 8, 2024

    Report

    Report Number
    1644487-2024-00270
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    November 29, 2023
    Report Date
    March 8, 2024
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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

    AN EXPLANTED FULL VNS SYSTEM WAS RECEIVED AND UNDERWENT PRODUCT ANALYSIS AFTER BEING RETURNED FOR AN UNKNOWN REASON. DURING INTERNAL GENERATOR DATA REVIEW, HIGH IMPEDANCE WAS SEEN A FEW MONTHS FOLLOWING IMPLANT. REASON FOR EXPLANT UNKNOWN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746518 LEAD MODEL 304 LEAD LYJ CYBERONICS - HOUSTON 304-20 3686

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female