BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3903348 · Received June 30, 2014

    Report

    Report Number
    1644487-2014-01640
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROLOGIST WAS HAVING ISSUES WITH HIS PROGRAMMING SYSTEM. THE WAND BATTERY WAS REPLACED AND WORKED WELL WITH ANOTHER PROGRAMMING SYSTEM. IT WAS NOTED THAT THE POWER ADAPTOR FOR THE NEUROLOGIST¿S HANDHELD DEVICE WAS FRAYED. THE FRAYED POWER ADAPTOR HAS NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    IT WAS DISCOVERED THAT THIS REPORT IS A DUPLICATE REPORT OF MFR. REPORT # 1644487-2014-01615. IF ANY ADDITIONAL RELEVANT INFORMATION IS OBTAINED IT WILL BE REPORTED IN MFR. REPORT # 1644487-2014-01615.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379860 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1073773

    Patients

    Seq Age Sex Outcome Treatment
    1