BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2971569 · Received February 21, 2013

    Report

    Report Number
    1644487-2013-00465
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THERE IS SOME TROUBLE WITH THE PROGRAMMING HANDHELD. IT WAS LATER CLARIFIED THAT THE PROGRAMMING SYSTEM IS GIVING A MESSAGE OF "COMMUNICATION ERROR" AND THAT A SOFT AND HARD RESET WAS PERFORMED BUT DID NOT RESOLVE THE ISSUE. THE HANDHELD WAS TRIED WITH ANOTHER WAND BUT IT STILL GAVE THIS MESSAGE. IT WAS REPORTED THAT THE HANDHELD WOULD BE RETURNED FOR PRODUCT ANALYSIS BUT IT HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE HANDHELD AND FLASHCARD WERE RETURNED FOR PRODUCT ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE HANDHELD AND NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD AND NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76358 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1