BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3002479 · Received March 13, 2013

    Report

    Report Number
    1644487-2013-00695
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 12, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS INITIAL REPORTED THAT THE SERIAL CABLE FOR THE PHYSICIAN HANDHELD IS FRAYED. IT WAS UNKNOWN WHEN OR HOW THE SERIAL CORD BECAME FRAYED. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE HANDHELD, FLASHCARD AND WAND WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO ANOMALIES ASSOCIATED WITH THE RETURNED SERIAL CABLE WERE IDENTIFIED. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO MALFUNCTION WAS IDENTIFIED WITH THE PROGRAMMING WAND. NO VISUAL OR MECHANICAL ANOMALY WAS IDENTIFIED. CONTINUITY TESTING OF THE SERIAL DATA CABLE AND THE BATTERY CABLE PASSED. THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104940 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1077277

    Patients

    Seq Age Sex Outcome Treatment
    1