BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3023976 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00839
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PHYSICIAN'S PROGRAMMING SYSTEM IS GIVING THEM SOME DIFFICULTIES. IT WAS DESCRIBED THAT WHEN USING THE PROGRAMMING EQUIPMENT TO INTERROGATE/PROGRAM, THEY HAVE TO HOLD THE SERIAL CABLE A CERTAIN WAY FOR IT TO WORK. IT WAS LATER STATED THAT THE PHYSICIAN'S PROGRAMMING SYSTEM WORKS FINE WITH A NEW SERIAL CABLE. IT WAS REPORTED THAT THE OLD SERIAL CABLE WOULD BE RETURNED FOR PRODUCT ANALYSIS BUT IT HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE HANDHELD SERIAL CABLE WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PRODUCT ANALYSIS WAS COMPLETED ON THE HANDHELD SERIAL CABLE. NO ANOMALIES ASSOCIATED WITH THE SERIAL CABLE WERE NOTED DURING TESTING. THE SERIAL CABLE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125925 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075842

    Patients

    Seq Age Sex Outcome Treatment
    1