BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1823596 · Received August 27, 2010

    Report

    Report Number
    1644487-2010-01965
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT THE VNS PATIENT WAS SEEN FOR A FOLLOW UP APPOINTMENT, AND THE PATIENT REPORTED HAVING HAD A FLURRY OF SEIZURES, BELOW THE PRE-VNS BASELINE A FEW WEEKS PRIOR TO THE OFFICE VISIT. THE PHYSICIAN REPORTED THAT WHEN THE DEVICE WAS INTERROGATED, THE OUTPUT CURRENT WAS SET TO 0MA, WHICH WAS NOT THE INTENDED SETTING. THE PHYSICIAN STATED THAT HE REPROGRAMMED THE DEVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, INCLUDING PROGRAMMING AND DIAGNOSTIC HISTORY FOR REVIEW, ARE UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521425

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR