BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4213356 · Received October 30, 2014

    Report

    Report Number
    1644487-2014-02890
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SERIAL CABLE WAS INADVERTENTLY DISCARDED. THEREFORE, ANALYSIS IS UNABLE TO BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING ISSUES CHARGING HER HANDHELD DEVICE. THE COMPONENTS OF THE PROGRAMMING SYSTEM WERE SWAPPED WITH KNOWN WORKING COMPONENTS WITH THE SUSPECT HANDHELD DEVICE; THE ISSUE WAS ISOLATED TO THE HANDHELD SERIAL CABLE. THE HANDHELD DEVICE THEN DISPLAYED A ¿MEMORY ERROR HAS BEEN DETECTED¿ MESSAGE WHICH RESOLVED AFTER A HARD RESET WAS PERFORMED. IT WAS NOTED THAT THE HANDHELD DEVICE WAS PERFORMING SLOWLY WHEN IN USE. THE FAULTY SERIAL CABLE HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696969 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 260 1077507

    Patients

    Seq Age Sex Outcome Treatment
    1