BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 17992529 · Received October 23, 2023

    Report

    Report Number
    1644487-2023-01524
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    June 28, 2023
    Report Date
    October 23, 2023
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE PATIENT'S DEVICE WAS AT EOS. INTERNAL GENERATOR DATA WAS NOTED TO BE SENT IN FOR REVIEW INTERNAL GENERATOR WAS RECEIVED AND IT WAS FOUND THAT THE GENERATOR'S BATTERY WAS PREMATURELY DEPLETING. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE DEVICE. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WAS HP STERILIZED PRIOR TO DISTRIBUTION. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847406 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 204765 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male