BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 8802500 · Received July 18, 2019

    Report

    Report Number
    1644487-2019-01400
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    April 25, 2019
    Report Date
    August 14, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA, INITIAL REPORT: OUTCOMES ATTRIBUTED TO ADVERSE EVENT INADVERTENTLY NOT SELECTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. THE EXPLANTED GENERATOR WAS DISCARDED BY THE FACILITY AND HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE. FURTHER INFORMATION WAS RECEIVED FROM THE PHYSICIAN'S OFFICE THAT THE BELIEVED CAUSE OF THE INCREASE IN SEIZURES WAS LOW BATTERY AND THAT THE INCREASE WAS ABOVE PRE-VNS BASELINE LEVELS. CLINIC NOTES RECEIVED FOR THE PATIENT INDICATED THAT THE DEVICE WAS AT IFI (INTENSIFIED FOLLOW-UP INDICATOR) = NO (25-50%) BATTERY.

    Description of Event or Problem · 1

    PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY AS THE GENERATOR WAS NEARING END OF SERVICE (LOW BATTERY). PATIENT'S MOTHER REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES. NO KNOWN 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
    596509 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 203814 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention