BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2101759 · Received May 10, 2011

    Report

    Report Number
    1644487-2011-01040
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN'S HANDHELD WAS FREEZING DURING DIAGNOSTICS AND WOULD THEN TURN OFF. THIS HAD HAPPENED WITH SEVERAL DIFFERENT PATIENTS. THE FLASHCARD WAS REMOVED AND RESEATED BUT IT DID NOT RESOLVE THE ISSUE. GOOD FAITH ATTEMPTS FOR MORE INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 840144

    Patients

    Seq Age Sex Outcome Treatment
    1