BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 18124509 · Received November 13, 2023

    Report

    Report Number
    1644487-2023-01629
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    October 19, 2023
    Report Date
    November 15, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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

    IMPLANT CARD WAS RECEIVED REPORTING THAT THE PATIENT'S GENERATOR WAS REPLACED. THE SUSPECT DEVICE WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 0

    UPDATE WAS RECEIVED THAT THE GENERATOR WAS INTERROGATED AND A THERAPY DISABLED MESSAGE WAS SEEN AGAIN; THERAPY WAS RE-ENABLED. IT WAS NOTED THAT THE PATIENT HAS ANOTHER DEVICE WITHIN CLOSE PROXIMITY OF THE VNS. ADDITIONAL TABLET DATA WAS RECEIVED FOR REVIEW. FROM REVIEW OF THE DECODER, BURST WATCHDOG TIMEOUTS WERE SEEN TWO ADDITIONAL TIMES. THE PATIENT WAS ABLE TO HAVE THERAPY ENABLED AGAIN AND DIAGNOSTICS WERE WITHIN NORMAL LIMITS AFTER THE EVENTS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FOLLOWING UP, WHEN INTERROGATING THE GENERATOR ERROR CODE 10 (BURST WATCHDOG TIMEOUT) WAS OBSERVED. IT WAS NOTED THAT THE AUTOSTIM WAS OFF. TABLET DATA WAS ALSO PROVIDED FOR REVIEW. THE PROVIDER ALSO ADDED THAT THE PATIENT WAS NOT EXPOSED TO ANY HIGH ENERGY FIELDS, DID NOT UNDERGO ANY RECENT MEDICAL PROCEDURES, AND DID NOT EXPERIENCED ANY ENVIRONMENTAL CHANGES THAT MAY IMPACT THE IPG. A BURST WATCHDOG TIMEOUT RESET IS A RISK MITIGATION TO ENSURE THE THERAPY (ON TIME) IS NOT DELIVERED FOR THE LONGER DURATION AND INTENDED TO COVER UNEXPECTED SCENARIOS. POTENTIAL CAUSES OF BURST WATCHDOG TIMEOUT FOR THIS DEVICE COULD BE A MEMORY ERROR (WHICH COULD NOT BE DETECTED AS THE FAILURE SIGNATURE IS NOT RECORDED IN THE FILE) OR A POSSIBLE FIRMWARE BUG. THE GENERATOR DATA DECODER CONFIRMS THAT THE BURST WATCHDOG TIMEOUT WAS ENCOUNTERED WHEN THE DEVICE WAS INTERROGATED. ACCORDING TO THE DATA, THERAPY WAS REENABLED FOLLOWING THE TIMEOUT ERROR AND SYSTEM DIAGNOSTICS WERE WITHIN NORMAL LIMITS AFTER EVENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042413 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male