BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3900440 · Received June 27, 2014

    Report

    Report Number
    1644487-2014-01617
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S MOTHER WAS CONCERNED BECAUSE THE PATIENT WAS EXPERIENCING MORE SEIZURES. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR FOLLOW-UP IN THREE MONTHS. IT IS UNKNOWN IF THE INCREASE IN SEIZURES IS ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377521 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 3222

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR