BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2193124 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01657
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011 A VNS TREATING PHYSICIAN REPORTED THAT THE VNS PT WAS IMPLANTED WITH A MODEL 103 GENERATOR ABOUT A YEAR AGO AND THAT YESTERDAY WHEN HE INTERROGATED THE GENERATOR, THE BATTERY STATUS SHOWED 100%. ON (B)(6) 2011 HE INTERROGATED THE GENERATOR AGAIN AND THE BATTERY WAS DOWN TO 10%. THE PHYSICIAN REPORTED THAT AT 10% THE BATTERY STILL SHOWED THE COLOR GREEN, WITH IFI = NO. THE PT IS AT VERY HIGH SETTINGS ACCORDING TO THE PHYSICIAN AND THAT YESTERDAY HE WAS PROGRAMMED AT 3.0MA. THE PHYSICIAN INCREASED THE PT TO 3.5MA ON (B)(6), 2011. THE PT'S SETTINGS ARE OUTPUT = 3.5MA/FREQUENCY = 30HZ/PULSE WIDTH = 500USEC/ON TIME = 30SEC/OFF TIME = 1.8MIN. THE DIFFERENT LEVELS OF THE BATTERY INDICATORS WERE EXPLAINED TO THE PHYSICIAN AND HE THEN REPORTED THAT THE PT'S DEVICE IS PROBABLY AT A QUARTER REMAINING. THE PHYSICIAN AGREED TO SEND A COPY OF THE PT'S PROGRAMMING HISTORY FROM THE PHYSICIAN'S HANDHELD TO THE MFR FOR REVIEW; HOWEVER IT HAS NOT BEEN RECEIVED TO DATE. THE PHYSICIAN NOTED THAT THE PT IS DOING VERY WELL WITH VNS AND IS HAVING NO SIDE EFFECTS. WHEN ADD'L INFO IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE MANUFACTURER'S CONSULTANT REPORTED THAT HE WOULD TRY AND OBTAIN A COPY OF THE PROGRAMMING SYSTEM FROM THE PHYSICIAN'S HANDHELD BUT THE COPY HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. WHEN ADDITIONAL INFORMATION HAS BEEN RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 840143

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR