BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2964161 · Received February 15, 2013

    Report

    Report Number
    1644487-2013-00419
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    A FORMER COMPANY REPRESENTATIVE'S PROGRAMMING SYSTEM WAS RETURNED TO THE MANUFACTURER WHEN THEY LEFT THE COMPANY. PRODUCT ANALYSIS WAS COMPLETED ON THE WAND, HANDHELD AND FLASHCARD. NO VISUAL OR MECHANICAL ANOMALY WAS IDENTIFIED WITH THE WAND. CONTINUITY TESTING OF THE SERIAL DATA CABLE AND THE BATTERY CABLE PASSED. THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE SYNC CABLE CONNECTOR ON THE BOTTOM OF THE HANDHELD WAS DAMAGED. BECAUSE OF THE DAMAGE, THE HANDHELD WAS UNABLE TO RECEIVE POWER FROM THE AC ADAPTER. THE CAUSE FOR THE DAMAGE TO THE CONNECTOR 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. 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
    66814 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS MODEL 250 840143

    Patients

    Seq Age Sex Outcome Treatment
    1