BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2180814 · Received July 7, 2011

    Report

    Report Number
    1644487-2011-01500
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE REGIONAL MANAGER REPORTED THAT HE WAS DOING AN UPGRADE ON A PHYSICIAN'S HANDHELD THAT WAS PLUGGED INTO THE WALL; HE WAS ABLE TO COMPLETE THE UPGRADE WITHOUT ANY PROBLEMS BUT AS SOON AS HE UNPLUGGED THE HANDHELD, IT WOULD NOT HOLD THE CHARGE AND WOULD GO DEAD. THE PHYSICIAN REPORTED THAT SHE HAS NOT EXPERIENCED ANY PROBLEMS WITH THE HANDHELD LIKE THAT. THE MANAGER TRIED A FEW MORE TIMES BUT THE HANDHELD CONTINUED TO LOSE CHARGE AS SOON AS IT WAS UNPLUGGED. THE HANDHELD AND FLASHCARD WERE RETURNED TO THE MFR FOR PRODUCT ANALYSIS ON (B)(6), 2011 THAT HAS NOT YET BEEN COMPLETED. WHEN ADD'L INFO IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250-8.0 887458

    Patients

    Seq Age Sex Outcome Treatment
    1