BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1101986 · Received August 6, 2008

    Report

    Report Number
    1644487-2008-01791
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 8, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 MANUFACTURER THAT HIGH LEAD IMPEDANCE WAS OBSERVED FROM BOTH NORMAL MODE AND SYSTEM DIAGNOSTICS TESTS, END OF SERVICE SET TO NO. X-RAY SNAP SHOTS WERE SENT TO MANUFACTURER TO REVIEW FOR A POTENTIAL LEAD FRACTURE. MANUFACTURER'S REVIEW OF THE X-RAY COULD NOT CONFIRM THE PRESENCE OF A LEAD FRACTURE DUE TO POOR IMAGE QUALITY OF THE X-RAYS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED "THE PATIENT WAS EXPLANTED." IT IS UNKNOWN IF THE LEAD WAS EXPLANTED OR ONLY THE GENERATOR AND IF A RE-IMPLANT OCCURRED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE ARE UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009121

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR