BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2920362 · Received January 17, 2013

    Report

    Report Number
    1644487-2013-00180
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    May 22, 2011
    Report Date
    December 18, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT SEIZURES WERE ON OCCASION WERE MORE SEVERE COMPARED TO PAST SEIZURES. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25313 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 010182

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR