BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1070001 · Received July 2, 2008

    Report

    Report Number
    1644487-2008-01500
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 5, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR THAT THE VNS PT WAS FEELING THAT THE STIMULATION WAS MORE INTENSE THAN IT HAD PREVIOUSLY FELT AFTER A FOLLOW UP VISIT WITH THE PHYSICIAN. THE REPORTER INDICATED THAT NO SETTING CHANGES WERE MADE AT THE OFFICE VISIT. ADDITIONAL INFO WAS RECEIVED WHICH REVEALED THAT AFTER REVIEWING DIAGNOSTIC HISTORY ON THE SITES HAND HELD, AND HIGH LEAD IMPEDANCE WAS NOTED ON A DIAGNOSTIC TEST PERFORMED ON THE PTS DEVICE. NO ADDITIONAL INFO WAS AVAILABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING PHYSICIAN HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 010182

    Patients

    Seq Age Sex Outcome Treatment
    1