BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 21830404 · Received April 11, 2025

    Report

    Report Number
    1644487-2025-00403
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 19, 2025
    Report Date
    June 30, 2025
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 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: CORRECTED INFORMATION MEDICAL DEVICE CODE, INITIAL REPORT: INADVERTENTLY LEFT OUT A090203 AND A160601.

    Description of Event or Problem · 0

    TABLET DATA WAS LATER RECEIVED AND REVIEWED. VOLTAGE FLUCTUATION AND FLASH ERROR WAS SEEN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON INTERROGATION GENERATOR BATTERY SHOWED 0% END OF SERVICE (EOS) WITH ERROR CODE 8 (VOLTAGE >EOS THRESHOLD). WHEN DIAGNOSTICS RAN LEAD IMPEDANCE WAS NOT AVAILABLE, GENERATOR BATTERY 75%-100%, OUTPUT CURRENT DISABLED. TROUBLESHOOTING INVOLVED ATTEMPTING TO RE-ENABLE THERAPY, PHYSICIAN ATTEMPTED AND STATED THEY COULD NOT RE-ENABLE THERAPY. REPRESENTATIVE STATED THAT THE DEVICE WAS CHECKED IN DECEMBER BATTERY WAS AT 75-100%. IT WAS ALSO STATED THERE WAS NO TRAUMA OR MEDICAL PROCEDURES RECENTLY EXPERIENCED BY THE PATIENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092269 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS - HOUSTON 103 205940

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male