BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2902298 · Received January 8, 2013

    Report

    Report Number
    1644487-2013-00083
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WAS NOT WORKING AND WAS FROZEN. FOLLOW UP FOUND THAT THE HANDHELD WAS FREEZING ON THE "INTERROGATION SUCCESSFUL" SCREEN REPEATEDLY. THE PHYSICIAN TOOK THE FLASHCARD OUT OF THE HANDHELD AND RESEATED IT, WHICH RESOLVED THE FROZEN SCREEN; HOWEVER, THE HANDHELD CONTINUALLY FROZE AT THE SAME SCREEN WHILE TRYING TO INTERROGATE. THE PHYSICIAN HAD ANOTHER WORKING HANDHELD IN THE OFFICE, SO NO PATIENTS WERE AFFECTED. THE HANDHELD IS PENDING RETURN FOR PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PHYSICIAN'S OFFICE FOUND THAT THE HANDHELD HAD BEEN DISCARDED AS THEY DID NOT REALIZE IT NEEDED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9676 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1075832

    Patients

    Seq Age Sex Outcome Treatment
    1