BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3922858 · Received July 9, 2014

    Report

    Report Number
    1644487-2014-01737
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD GREAT IMPROVEMENT IN HIS EPILEPSY WITH VNS THERAPY, BUT LATER ON EXPERIENCED A GREAT RELAPSY. IT WAS REPORTED THAT THERE HAS BEEN NO IMPROVEMENT SINCE THE RELAPSE. IT WAS REPORTED THAT DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE PATIENT'S PARENTS DO NOT WANT TO HAVE THE DEVICE PROGRAMMED OFF BECAUSE THEY FEEL THAT THE PATIENT HAS EXPERIENCED PSYCHOLOGICAL IMPROVEMENT. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399428 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 3273

    Patients

    Seq Age Sex Outcome Treatment
    1