BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1172126 · Received September 18, 2008

    Report

    Report Number
    1644487-2008-02253
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEY HAD A PROBLEM WITH A PROGRAMMING SESSION WITH THEIR PATIENT. REPORTED "PATIENT WAS IN FOR OFFICE VISIT AND SHE INTERROGATED PATIENT AND WHEN SHE PRESSED THE INTERROGATE BUTTON THE PATIENT IMMEDIATELY STARTED SCREAMING THAT SHE COULDN'T BREATH." REPORTER INDICATED THAT PRIOR TO THIS THE PATIENT WAS PROGRAMMED AT 1.25 OUTPUT CURRENT WITH 250 PULSE WIDTH. THE SETTINGS WERE CHECKED ON THE HANDHELD AND IT WAS SET TO 1.5 OUTPUT CURRENT AND 500 PULSE WIDTH. THE SETTINGS WERE IMMEDIATELY CHANGED BACK TO WHAT PATIENT WAS PREVIOUSLY ON AND THEN IN THE COURSE OF THE OFFICE VISIT SHE CHANGED PATIENT'S SETTINGS TO 1.50 OUTPUT CURRENT, 250 PULSE WIDTH BEFORE PATIENT LEFT OFFICE WITHOUT DIFFICULTY OR FURTHER INCIDENT. MANUFACTURER IS PENDING RECEIPT OF THE PROGRAMMING SYSTEM FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 584952

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR