BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1191921 · Received October 1, 2008

    Report

    Report Number
    1644487-2008-02377
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT WAS "UNABLE TO FEEL STIMULATION AS SHE USED TO" AND THAT AN INTERROGATION OF THE PT'S DEVICE HAD CONFIRMED THAT HER DEVICE WAS NO LONGER AT PREVIOUSLY PROGRAMMED SETTINGS. FOLLOW UP WITH THE REPORTER REVEALED THAT THE PARAMETER CHANGED DUE TO A COMMUNICATION INTERRUPTION DURING DIAGNOSTICS PERFORMED AT THE PT'S LAST VISIT. TROUBLESHOOTING WAS PERFORMED AND IT WAS REVEALED THAT THE REPORTER'S DELL X5 HAD BEEN PLUGGED INTO THE WALL DURING THE DIAGNOSTIC TESTING, CAUSING THE EVENT. LATER, THE REPORTER STATED THAT HE WAS ABLE TO SUCCESSFULLY INTERROGATE AND REPROGRAM THE PT'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 522003

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR