BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1823572 · Received August 27, 2010

    Report

    Report Number
    1644487-2010-01961
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON'S HANDHELD COMPUTER WOULD NOT HOLD CHARGE. THE SURGEON STATED THAT THE HANDHELD WOULD CHARGE AND AFTER BEING UNPLUGGED FROM THE AC POWER SUPPLY THE BATTERY DEPLETED RAPIDLY UP TO 25%. THE REPORTED HANDHELD COMPUTER WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY UNDERGOING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 678297

    Patients

    Seq Age Sex Outcome Treatment
    1