BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2062201 · Received April 11, 2011

    Report

    Report Number
    1644487-2011-00766
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 14, 2011
    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 DURING AN ATTEMPT TO UPGRADE A PHYSICIAN'S DELL X50 HANDHELD DEVICE, A COMPANY REP NOTED THAT THE HANDHELD WILL NOT STAY ON . THE REP OBSERVED THAT THE POWER LIGHT WILL TURN OFF WHEN THE HANDHELD IS MOVED. IF THE SERIAL ADAPTER CABLE AND POWER CORD ARE MOVED AROUND, THE LIGHT WILL COME ON BUT WILL NOT STAY ILLUMINATED. THE PHYSICIAN'S OFFICE CONFIRMED THAT THIS ISSUE HAS BEEN OCCURRING FOR SEVERAL MONTHS AND THEY WERE USING A DIFFERENT HANDHELD ON THEIR VNS PATIENTS. WHEN THE COMPANY REP USED HIS OWN POWER CORD AND SERIAL ADAPTER CABLE, HE WAS ABLE TO USE THE HANDHELD WITHOUT ANY ISSUES. THE SITE HAS BEEN SENT REPLACEMENT CABLES/CORDS AND GOOD FAITH ATTEMPTS TO HAVE THE POWER CORD AND SERIAL ADAPTER CABLE RETURNED TO THE MFR FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 834042

    Patients

    Seq Age Sex Outcome Treatment
    1