BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3204014 · Received July 3, 2013

    Report

    Report Number
    1644487-2013-02028
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    April 12, 2013
    Report Date
    June 12, 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

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IT WAS FOUND THAT THE INITIAL MDR INADVERTENTLY LISTED THE INCORRECT PRODUCT INFORMATION. THIS INFORMATION WAS CORRECTED ON THIS SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE PROGRAMMING SYSTEM WAS RETURNED ON (B)(4) 2013. AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD. THE BACK-UP BATTERY WAS REMOVED. THE BACK-UP BATTERY VOLTAGE WITH NO LOAD MEASURED 482MV (NOMINAL 3V). THIS IS AN INDICATION THAT THE BACK-UP BATTERY HAS BEEN DEPLETED. THE BACK-UP BATTERY INDICATOR READ 0%. THIS IS EXPECTED BECAUSE THE BACK-UP BATTERY WILL DISCHARGE IF THE UNIT IS NOT SUPPORTED BY AN EXTERNAL POWER SOURCE OR BY MAIN BATTERY POWER. A KNOWN GOOD BACK-UP BATTERY WAS SUBSTITUTED INTO THE HANDHELD AND THE BATTERY INDICATOR READ 100%. THIS IS EVIDENCE THAT THE HANDHELD BATTERY INDICATOR IS OPERATING PROPERLY. NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD. DURING THE ANALYSIS SOME MAC OS X FILES WERE IDENTIFIED ON THE FLASHCARD, GIVING THE INDICATION THAT THE FLASHCARD HAD BEEN INSERTED INTO A MAC OS X DEVICE. THE FILE AND FOLDERS HAD NO IMPACT ON THE SOFTWARE PERFORMANCE. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS DELL X5 COMPUTER WITH VERSION 8.1 SOFTWARE WAS FREEZING DURING INTERROGATION, AND THIS HAD BEEN OCCURRING FOR THE PREVIOUS TWO MONTHS. THE SCREEN FREEZE USED LAST 2-3 MINUTES, AND NOW LASTS AN HOUR. ALL CONNECTIONS WERE REPORTED TO BE SECURE, AND PERFORMING A HARD RESET ON THE COMPUTER DID NOT RESOLVE THE SCREEN FREEZING. ATTEMPTS FOR RETURN OF THE COMPUTER ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305256 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1063525

    Patients

    Seq Age Sex Outcome Treatment
    1