BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 21252290 · Received January 28, 2025

    Report

    Report Number
    1644487-2025-00072
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    January 3, 2025
    Report Date
    April 30, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    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 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 FURTHER REPORTED THAT THE PATIENT UNDERWENT A GENERATOR REPLACEMENT DUE TO BATTERY DEPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENTS FATHER THAT THE PHYSICIAN NOTED THE PATIENT'S BATTERY WAS LIKELY DEPLETED OR AT NEAR END-OF-SERVICE (NEOS), AS THE PATIENT'S SEIZURES HAVE DRAMATICALLY INCREASED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 0

    THE SUSPECT DEVICE WAS RECEIVED AND UNDERWENT PRODUCT ANALYSIS. AN INTERROGATION, A SYSTEM DIAGNOSTIC TEST, AND A WANDCOMM DIAG WERE PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWED A NEOS CONDITION) WAS PERFORMED. THE PULSE GENERATOR WAS OPENED, THE MEASURED BATTERY VOLTAGE SHOWED A NEOS CONDITION. A COMPREHENSIVE AUTOMATED PCBA ELECTRICAL EVALUATION AND A BATTERY LIFE CALCULATION WERE PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. PA WORKSHEET WAS REVIEWED AND SHOWED NO ANOMALIES. WANDCOMM DATA WAS REVIEWED AND SHOWED NO ANOMALIES. DATA DUMP WAS REVIEWED AND SHOWED NO ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607462 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 204741 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other