BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3093780 · Received May 6, 2013

    Report

    Report Number
    1644487-2013-01245
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 11, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    A PATIENT'S MOTHER CALLED AND REPORTED THAT HER CHILD IS HAVING MORE SEIZURES, SO SHE STARTED WONDERING HOW THE DEVICE WAS FUNCTIONING. SHE WAS NOT SURE IF THE MAGNET ACTIVATIONS WERE WORKING AND CALLED TO ASK INSTRUCTIONS ON HOW TO SWIPE THE MAGNET CORRECTLY. GOOD FAITH ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN ATTAINED AT THIS TIME. EXACT DATE OF THEIR INCREASED SEIZURES IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196356 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS INC 103 201956

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR