BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2171061 · Received June 30, 2011

    Report

    Report Number
    1644487-2011-01462
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN NOTED THAT UPON INTERROGATION OF THE PT'S VNS, MULTIPLE MAGNET ACTIVATIONS WERE SHOWN ON THE SAME LINE. A MANUFACTURER INVESTIGATION HAS DETERMINED THAT THE ROOT CAUSE FOR PREVIOUS CASES OF MAGNET ACTIVATIONS BEING DISPLAYED AS MULTIPLE DATES/TIMES PER ROW IS DUE TO THE LOCAL ARRAY (TDATESTR[255]) BEING MIS-DECLARED AS STATIC VARIABLE, HOWEVER, THE TRIGGER FOR THIS EVENT HAS BEEN IDENTIFIED TO BE THE RESULT OF THE GENERATOR'S TOTAL OPERATING TIME ROLLING OVER. THE EVENT WILL BE CORRECTED ONCE 15 MAGNET ACTIVATIONS HAVE REGISTERED FOLLOWING THE TOTAL OPERATING TIME ROLLOVER. BASED ON THE DATE OF MANUFACTURE FOR THIS GENERATOR, THE GENERATOR TOTAL OPERATING TIME LIKELY ROLLED OVER APPROXIMATELY 2.5 MONTHS PRIOR TO THE DATE THE REPORT WAS RECEIVED. BASED ON THE PT'S MAGNET ACTIVATION HISTORY, THE PT PERFORMS APPROXIMATELY 28 - MAGNET SWIPES PER YEAR. IT IS UNLIKELY THAT THIS PT WOULD HAVE PERFORMED 15 MAGNET SWIPES FROM THE DATE OF ROLLOVER TO THE DATE OF THE REPORT. THIS ISSUE DOES NOT AFFECT THE PERFORMANCE OF THE DEVICE. NO ADVERSE EVENTS HAVE BEEN REPORTED. ATTEMPTS FOR FURTHER PROGRAMMING HISTORY TO CONFIRM THE EVENTS ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR