BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2190785 · Received July 26, 2011

    Report

    Report Number
    1644487-2011-01687
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    May 5, 2005
    Report Date
    July 8, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A "REAL LONG" GENERALIZED SEIZURE ON (B)(6) 2005. THE PT'S HUSBAND ATTEMPTED TO SWIPE THE MAGNET TO ABORT THE SEIZURE HOWEVER IT DID NOT SEEM TO HAVE ANY EFFECT SO HE SWIPED THE MAGNET AGAIN A FEW SECONDS LATER. THE PHYSICIAN EXPLAINED TO THE PT AND HER HUSBAND THE PROPER WAY TO SWIPE THE MAGNET SO THAT THEY WAIT FOR ONE CYCLE TO COMPLETE PRIOR TO SWIPING AGAIN. THE PT WAS NOT TAKING ANY MEDICATIONS FOR HER SEIZURES SO THE PHYSICIAN PRESCRIBED DIASTAT (15 MG) FOR THE PT TO TAKE FOR ANY SEIZURES THAT LAST LONGER THAN FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 011066

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention