BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1970041 · Received January 14, 2011

    Report

    Report Number
    1644487-2011-00061
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR A ROUTINE FOLLOW UP VISIT AND UPON INTERROGATION OF THE VNS PULSE GENERATOR, THE SETTINGS WERE NOT AT THE INTENDED SETTINGS, AND IT WAS SHOWING THAT THE OUTPUT CURRENT WAS SET TO 0MA, WHERE IT WAS EXPECTED TO BE 1.75MA. THE PHYSICIAN INDICATED THAT THE PATIENT WAS SEEN PREVIOUSLY APPROXIMATELY A MONTH PRIOR, AND STATED A DIAGNOSTIC TEST WAS PERFORMED AT THAT TIME. THE MANUFACTURER REPRESENTATIVE WAS AT THE SITE WHEN THE SETTINGS WERE NOTED TO BE AT THE INCORRECT SETTINGS, AND PROVIDED THE PHYSICIAN WITH THE RECOMMENDATION TO PERFORM FINAL INTERROGATIONS OF THE GENERATOR AS A LAST STEP AT FOLLOW UP VISITS TO ENSURE THE DEVICE IS PROGRAMMED TO THE CORRECT SETTINGS. GOOD FAITH ATTEMPTS TO OBTAIN PROGRAMMING HISTORY AS WELL AS THE SOFTWARE AND HANDHELD LOT AND SERIAL NUMBERS HAVE BEEN MADE, HOWEVER, THE INFORMATION HAS NOT BEEN COMMUNICATED TO DATE. BASED ON THE INTERROGATION SETTINGS, IT IS LIKELY THAT A DIAGNOSTIC TEST WAS INTERRUPTED BY A COMMUNICATION FAULT AT THE PREVIOUS FOLLOW UP VISIT, WHICH MAY HAVE CAUSED THE SETTING TO CHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR