BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1070004 · Received July 2, 2008

    Report

    Report Number
    1644487-2008-01526
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 2, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. CODE: X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. CODE: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT PRESENTED WITH HIGH IMPEDANCE ON DIAGNOSTIC TESTING. THERE IS NO REPORT OF TRAUMA OR MANIPULATION. A BATTERY LIFE CALCULATION REVEALED THE GENERATOR IS 0.29 YEARS UNTIL THE ERI=YES. THE MFR REVIEWED X-RAYS AND NO OBVIOUS ANOMALIES WERE OBSERVED THAT COULD BE CONTRIBUTING TO THE REPORTED HIGH IMPEDANCE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30 6736

    Patients

    Seq Age Sex Outcome Treatment
    1