BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1800084 · Received August 11, 2010

    Report

    Report Number
    1644487-2010-01842
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SITE'S (B)(6) HANDHELD DEVICE WAS NOT FUNCTIONING PROPERLY. WHILE THE SITE WAS TRYING TO SET THE TIME, THEY RECEIVED A WARNING MESSAGE STATING THAT THE BATTERY WAS LOW AND THEN THE HANDHELD TURNED OFF. THE NURSE WHO CALLED IN STATED THAT WHENEVER THE PHYSICIAN TRIES TO USE THE HANDHELD, IT WILL TURN OFF IF NOT PLUGGED IN. ALL THE CABLES WERE CHECKED AND FOUND TO BE SECURE BUT THE POWER LIGHT WOULD NOT STAY ON. A NEW POWER CORD WAS SENT TO THE SITE TO SEE IF THIS WOULD RESOLVE THE ISSUE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO AS WELL AS OBTAIN THE POWER CORD IN QUESTION FOR PRODUCT ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 749110

    Patients

    Seq Age Sex Outcome Treatment
    1