BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3870068 · Received June 12, 2014

    Report

    Report Number
    1644487-2014-01488
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    September 1, 2012
    Report Date
    May 14, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 NOTED THAT THE PATIENT SUFFERED A PROLONGED SEIZURE LASTING SEVERAL HOURS IN (B)(6) 2012. IT WAS NOTED THAT THE PATIENT BEGAN HAVING AN INCREASE IN AGGRESSIVE BEHAVIOR AFTER THAT. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348295 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 201565

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other