BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2862447 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03269
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012 THAT THE PHYSICIAN WAS HAVING TROUBLE WITH HIS PROGRAMMING SYSTEM. THIS HAD BEEN OCCURRING FOR ABOUT A WEEK. THEIR HANDHELD DEVICE WOULD INTERMITTENTLY GIVE A COMMUNICATION ERROR MESSAGE DESPITE THE WAND BATTERY BEING GOOD AND THE PROGRAMMING SYSTEM NOT BEING PLUGGED IN TO THE OUTLET. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS ISOLATED TO THE SERIAL CORD ADAPTER. IT WAS REPORTED THAT THE SERIAL CABLE WOULD RATTLE WHEN SHAKEN AND THAT THE HANDHELD AND WAND WORKED WHEN USING A DIFFERENT SERIAL ADAPTER CABLE. THE CABLE WAS RETURNED ON (B)(6) 2012 AND ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE CABLE WAS RETURNED ON (B)(6) 2012. PRODUCT ANALYSIS ON THE SERIAL CABLE WAS COMPLETED ON (B)(4) 2012. AN ANALYSIS WAS PERFORMED ON THE RETURNED SERIAL CABLE AND THE REPORTED ALLEGATION WAS NOT VERIFIED. NO ANOMALIES ASSOCIATED WITH THE SERIAL CABLE WERE NOTED DURING TESTING. ADDITIONALLY IT WAS NOTED THAT NO 'RATTLING NOISES' WERE HEARD DURING ANALYSIS. THE SERIAL CABLE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075378

    Patients

    Seq Age Sex Outcome Treatment
    1