BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3231183 · Received July 17, 2013

    Report

    Report Number
    1644487-2013-02156
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO REINSTALL THE SOFTWARE ON HIS HANDHELD THE SCREEN FROZE AT ¿WINDOWS MOBILE¿ AND WOULD NOT RECOGNIZE ANY MANIPULATIONS AT ALL. THE BATTERY WAS CHECKED, THE LOCK BUTTON, AND THE SOFTWARE WAS RESET AGAIN BUT THIS DID NOT FIX THE ISSUE. IT WAS LATER REPORTED THAT THE ISSUE HAS NOT BEEN RESOLVED. A HARD RESET WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE. IT WAS STATED THAT THE HANDHELD WOULD NOT BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331254 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC 250-8.1 1077507

    Patients

    Seq Age Sex Outcome Treatment
    1