BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3841020 · Received May 30, 2014

    Report

    Report Number
    1644487-2014-01386
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE WAS HAVING ISSUES WITH HER HANDHELD DEVICE. TROUBLESHOOTING WAS PERFORMED AND IT WAS DETERMINED THAT THE POWER ADAPTOR REQUIRED SPECIFIC POSITIONING IN ORDER TO CHARGE THE DEVICE PROPERLY. THE HANDHELD DEVICE AND POWER ADAPTER HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    THE HANDHELD AND FLASHCARD WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON 07/16/2014. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD WOULD NOT POWER ON USING A KNOWN GOOD AC ADAPTER. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH DAMAGED HANDHELD SYNC CONNECTOR LEADS TO THE PCB. BECAUSE OF THE DAMAGE, THE HANDHELD WAS UNABLE TO RECEIVE POWER FROM THE AC ADAPTER. THE CAUSE FOR THE DAMAGE TO THE CONNECTOR LEADS AND SOLDER CONNECTIONS IS MOST LIKELY ASSOCIATED WITH MISHANDLING OF THE DEVICE AS IT APPEARS THE CONNECTOR DETENTS ARE NOT BEING COMPRESSED WHEN REMOVING OR MANIPULATING THE SERIAL DATA CABLE, THUS PLACING AN EXTENSIVE AMOUNT OF FORCE ON THE PCB AND ATTACHED CABLE RECEPTACLE. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON 07/16/2014. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD AND THE REPORTED ALLEGATION WAS VERIFIED. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317995 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063524

    Patients

    Seq Age Sex Outcome Treatment
    1