BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2950376 · Received February 8, 2013

    Report

    Report Number
    1644487-2013-00338
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PHYSICIAN'S PROGRAMMING SYSTEM "NEEDS REPAIR". HE PHYSICIAN'S NURSE STATED THAT THE PROGRAMMING SYSTEM IS "NOT PICKING UP A SIGNAL AT ALL". THE PHYSICIAN HAS OTHER PROGRAMMING SYSTEMS THAT THEY HAVE BEEN ABLE TO SUCCESSFULLY USE TO INTERROGATE PATIENTS. ATTEMPTS FOR FURTHER INFORMATION ARE UNDERWAY BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE PROGRAMMING SYSTEM IS NOW WORKING PROPERLY. ONE OF THE PHYSICIANS AT THE OFFICE FOUND A COUPLE OF THINGS WRONG WITH THE HANDHELD; THE BACK LATCH WAS OPEN AND THE FLASHCARD WASN'T INSERTED ALL THE WAY. HE FIXED THESE COUPLE OF THINGS AND NOW THE PROGRAMMING SYSTEM WORKS FINE AND THE OFFICE WANTS TO KEEP IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54978 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. 250-7.0 366988

    Patients

    Seq Age Sex Outcome Treatment
    1