BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1133585 · Received August 19, 2008

    Report

    Report Number
    1644487-2008-01952
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT DURING A DOSING APPOINTMENT WITH THE VNS PT, THE PHYSICIAN GOT THE ERROR MESSAGE "PROGRAMMED CURRENT POSSIBLY NOT DELIVERED AT SPECIFIED LEVEL, (POSSIBLY LIMITED BY BATTERY VOLTAGE, LEAD IMPEDANCE OR OTHER REASONS)." THIS ERROR MESSAGE WAS SEEN FOLLOWING TWO INTERROGATIONS OF THE DEVICE. DIAGNOSTICS WERE THEN PERFORMED ON THE DEVICE THAT INDICATED THE DEVICE WAS WORKING WITHIN NORMAL LIMITS. A THIRD INTERROGATION WAS DONE WHICH WAS SUCCESSFUL. REVIEW OF PROGRAMMING HISTORY REVEALED NO ANOMALIES WITH THE PT'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200778

    Patients

    Seq Age Sex Outcome Treatment
    1