BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 303

    MDR report key: 17755115 · Received September 15, 2023

    Report

    Report Number
    1644487-2023-01321
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 15, 2023
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS SEEN UPON INTERROGATION. LATER IT WAS REPORTED THAT ONLY THE GENERATOR WAS REPLACED AND THE LEADS REMAIN IMPLANTED. THE NEWLY PLACED GENERATOR WAS FUNCTIONING PROPERLY AS DIAGNOSTICS AND HEARTBEAT DETECTION WERE WITHIN NORMAL LIMITS AND THERE WERE NO OBSERVED PROBLEMS. THEREFORE THEY ELECTED TO LEAVE THE LEADS IMPLANTED. THE EXPLANTED GENERATOR IS NOT AVAILABLE FOR RETURN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256337 LEAD MODEL 303 LEAD LYJ CYBERONICS - HOUSTON 303-20 200265

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female