BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2062213 · Received April 11, 2011

    Report

    Report Number
    1644487-2011-00771
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PHYSICIAN'S (B)(4) X50 HANDHELD DEVICE WOULD NOT HOLD A CHARGE. A COMPANY REP VISITED THE SITE TO PERFORM TROUBLESHOOTING AND FOUND THAT THE CONNECTOR TO THE HANDHELD APPEARED TO BE DAMAGED AS THE HANDHELD WOULD ONLY CHARGE WHEN THE CORD WAS HELD A CERTAIN WAY. THERE WAS NO EVIDENCE OF THE BATTERY ON THE HANDHELD WAS SWOLLEN AND THE HANDHELD IS TYPICALLY STORED ON A DESK WHEN NOT IN USE. A REPLACEMENT HANDHELD WAS SENT TO THE PHYSICIAN AND THE DELL X50 HANDHELD AND FLASHCARD WERE RETURNED TO THE MFR FOR ANALYSIS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECS. DURING ANALYSIS OF THE HANDHELD, IT WAS IDENTIFIED THAT THE SYNC CONNECTOR ON THE BOTTOM OF THE HANDHELD WAS DAMAGED. THE CAUSE FOR THE DAMAGE TO THE CONNECTOR COULD NOT BE DETERMINED BASED ON THE RETURNED HANDHELD. HOWEVER, BASED ON THE DAMAGED CONNECTOR, IT 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. NO OTHER ANOMALIES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 834042

    Patients

    Seq Age Sex Outcome Treatment
    1