BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2201290 · Received August 3, 2011

    Report

    Report Number
    1644487-2011-01763
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN HANDHELD WAS HAVING PROBLEMS. THE SERIAL CABLE WOULD HAVE TO BE HELD A CERTAIN WAY FOR IT TO SUCCESSFULLY WORK. THE OFFICE IS ABLE TO GET THE PROGRAMMING SYSTEM TO WORK BUT IT IS BOTHERSOME AND REQUESTED A NEW SERIAL CORD. THE HANDHELD IS ALSO NOT HOLDING A CHARGE LIKE IT USED TO LIKELY DUE TO THE SERIAL CABLE. THERE WERE NO VISUAL PROBLEMS WITH THE SERIAL CABLE OR THE CONNECTION TO THE HANDHELD. THE SERIAL CABLE HAS BEEN RETURNED TO THE MFR FOR EVAL. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250-8.0 879565

    Patients

    Seq Age Sex Outcome Treatment
    1