BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 5500705 · Received March 15, 2016

    Report

    Report Number
    1644487-2016-00552
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    October 30, 2015
    Report Date
    February 19, 2016
    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

    IT WAS REPORTED THAT A CUSTOMER'S PROGRAMMING COMPUTER WILL NOT TURN ON DESPITE GOOD CHARGE OF THE DEVICE BATTERY. A HARD RESET WAS PERFORMED WITHOUT SOLVING THE REPORTED ISSUE. A NEW MOTION TABLET WAS SENT TO THE CUSTOMER TO BE ABLE TO FOLLOW UP THE PATIENT IMPLANTED WITH ASPIRESR DEVICES AS WELL. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE PROGRAMMING COMPUTER PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. THE SUSPECTED PROGRAMMING COMPUTER WAS RETURNED TO THE MANUFACTURER. THE ANALYSIS IS UNDERWAY BUT IT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD AND THE REPORTED ALLEGATION WAS NOT VERIFIED. 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 AND NO ANOMALIES WERE IDENTIFIED DURING THE ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE FLASHCARD CONTAINED A MAC OSX OPERATING SYSTEM FILE AND FOLDERS. THE PRESENCE OF THE FILE AND FOLDERS IS AN INDICATION THAT THE FLASHCARD WAS INSERTED INTO A DEVICE USING THE MAS OSX OPERATING SYSTEM. THE FILE AND FOLDERS HAD NO IMPACT ON THE VNS SOFTWARE PERFORMANCE. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156198 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063525

    Patients

    Seq Age Sex Outcome Treatment
    1