BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 8530349 · Received April 19, 2019

    Report

    Report Number
    1644487-2019-00753
    Event Type
    Injury
    Date Received
    April 19, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 20, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED FOR THE PATIENT'S BATTERY REPLACEMENT SURGERY. THE SURGERY WAS INDICATED TO BE DUE TO PROPHYLACTIC REASONS. A FORM WITH THE SETTINGS AND DIAGNOSTICS OF THE PATIENT'S DEVICE NOTED THAT THE OLD GENERATOR SHOWED OK SYSTEM DIAGNOSTICS RESULTS WITH NEAR END OF SERVICE = YES BATTERY LIFE. NO ADDITIONAL RELEVANT INFORMATION WAS RECEIVED TO DATE.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED STATING THAT THE PATIENT WAS STARTING TO HAVE NOCTURNAL SEIZURES. THE INCREASED SEIZURES WERE SUSPECTED TO BE DUE TO THE DEVICE REACHING NEOS CONDITION. IT WAS STATED THAT VNS WAS INTERROGATED AND SETTINGS WERE ADJUSTED. DIAGNOSTICS WERE PERFORMED, HOWEVER WERE NOT PROVIDED. NO ADDITIONAL, RELEVANT INFORMATION WAS RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325965 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 201721

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention