BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2182365 · Received July 11, 2011

    Report

    Report Number
    1644487-2011-01546
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT'S GENERATOR WAS UNABLE TO BE INTERROGATED WITH THE VNS PROGRAMMING SYSTEM. THE PT'S VNS GENERATOR IS LIKELY NOT AT END OF SERVICE. THE PROGRAMMING SYSTEM WAS USED SUCCESSFULLY ON OTHER VNS PTS THAT DAY. THE PT IS NONVERBAL AND CANNOT STATE IF VNS STIMULATION IS FELT. THE PT WILL NOT BE SEEN AGAIN FOR F/U UNTIL (B)(6) 2011. ATTEMPTS TO INTERROGATE THE GENERATOR AGAIN WILL OCCUR AT THE OFFICE VISIT ON (B)(6) 2011. A VNS BATTERY ESTIMATE YIELDED APPROXIMATELY 3.34 YRS REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200863

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR