BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2190804 · Received July 26, 2011

    Report

    Report Number
    1644487-2011-01681
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A GENERATOR REPLACEMENT PROCEDURE THE PT WAS EXPERIENCING TACHYCARDIA. THE SURGEON PERFORMED DIAGNOSTICS ON THE PT, AND THEN PROCEEDED TO PROGRAM THE PT TO 0.25MA. THE PT THEN STARTED SHOWING SIGNS OF TACHYCARDIA. AT THAT TIME, THE PT'S DEVICE WAS DISABLED AND THE TACHYCARDIA RESOLVED. THE EXACT DIAGNOSTIC RESULTS ARE NOT KNOWN. IT IS ALSO UNK IF ANY OTHER SETTINGS, BESIDES THE PROGRAMMING OF THE OUTPUT CURRENT, WERE CHANGED. ATTEMPTS FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 LYJ CYBERONICS, INC. 104 2916

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention