BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3163168 · Received June 11, 2013

    Report

    Report Number
    1644487-2013-01746
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    March 1, 2010
    Report Date
    May 14, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    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 HAD AN INCREASE IN SEIZURES. FOLLOW-UP WITH THE OFFICE INDICATED THAT THERE WERE NOT MEDICATION OR SETTING CHANGES THAT SHE MAY HAVE CONTRIBUTED TO INCREASE IN SEIZURES AND NOTHING WAS DONE AS A RESULT OF THE SEIZURES. IT WAS UNKNOWN IF THE INCREASE IN SEIZURES WERE RELATED TO VNS OR THE RELATIONSHIP TO BASELINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263925 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 013315

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR