BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2022965 · Received February 24, 2011

    Report

    Report Number
    1644487-2011-00337
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011, THAT A MAGNET DISPLAY ERROR OCCURRED WHEN A DOCTOR WAS VISITING WITH A PT ON (B)(6) 2011. THE DOCTOR CLAIMED THAT "THE DATE OF THE ACTIVATIONS REMAINED THE SAME, BUT EACH TIME STAMP WOULD APPEAR UNDER THE SAME DATE", THAT IS A DIFFERENT INDEX. EACH INDEX WOULD CONTAIN THE SAME DATE AND TIME STAMPS, BUT ONE LESS TIME STAMP THAN THE PREVIOUS INDEX. F/U WITH THE PHYSICIAN WAS MADE AND THE ERROR WAS SAID TO LOOK LIKE A PYRAMID SHAPE - EVERY ENTRY LINE HAD ONE LESS TIME STAMP THAN THE PREVIOUS ENTRY. IT WAS EXPLAINED THAT THIS ERROR WAS TRIGGERED BY A ROLL-OVER IN THE COUNTER OF THE PATIENT'S GENERATOR AFTER IT REACHES 65536 HOURS, WHICH CAUSES THE VNS SOFTWARE TO INCORRECTLY DISPLAY THE MAGNET SWIPES; HOWEVER A COMPANY REP STATED THAT THE PATIENT'S GENERATOR HAD NOT YET ROLLED OVER AS THE PATIENT'S COUNTER WAS AT 60698 HOURS ON (B)(6) 2011. GOOD FAITH ATTEMPTS TO DATE FOR MORE INFO ON THE ERROR HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 855099

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR