BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1191539 · Received September 26, 2008

    Report

    Report Number
    1644487-2008-02352
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 1, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STUDY COORDINATOR WAS HAVING DIFFICULTY GETTING HER DELL X5 HANDHELD TO INTERROGATE DEVICES. SHE CLARIFIED BY STATING THAT THE DEVICES WOULD BE INTERROGATED SUCCESSFULLY WITH THE HANDHELD BUT THAT THERE WOULD BE A SIGNIFICANT DELAY IN GETTING THIS ACCOMPLISHED. SHE STATED THAT THE DEVICE IS NOT ALWAYS CHARGED PROPERLY BETWEEN USES AND UNDERSTANDS THAT THIS MAY BE CONTRIBUTING TO HER EVENT. THE STUDY COORDINATOR CONCLUDED BY STATING THAT SHE DID NOT WANT TO RETURN THE DEVICE AS SHE IS SURE IT IS FUNCTIONING PROPERLY BUT SHE DID WANT TO KNOW IF THERE IS ANY WAY TO AVOID IT IN THE FUTURE. THE MANUFACTURER RECOMMENDED THAT SHE COULD RE-INSERT THE FLASHCARD OR PERFORM A SOFT RESET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 521407

    Patients

    Seq Age Sex Outcome Treatment
    1