BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1990009 · Received February 3, 2011

    Report

    Report Number
    1644487-2011-00154
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 6, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THAT A VNS PT COMPLAINED THAT SHE COULD NO LONGER FEEL HER VNS STIMULATION AND DID NOT COUGH UPON MAGNET SWIPE. THE TREATING NEUROLOGIST PERFORMED A SYSTEMS DIAGNOSTIC TEST AND RECEIVED A HIGH LEAD IMPEDANCE. THE NEUROLOGIST ELECTED TO KEEP THE GENERATOR ON DESPITE MANUFACTURER'S SUGGESTION TO TURN THE GENERATOR OFF. MANUFACTURER RECEIVED THE X-RAYS AND THE REVIEW OF X-RAY REVEALED THAT THE ALIGNMENT OF THE POSITIVE AND NEGATIVE ELECTRODES APPEARED TO BE NORMAL. THE LEAD WAS ROUTED TOWARDS THE GENERATOR. THE GENERATOR WAS PLACED ON THE LEFT CHEST AND A SMALL AMOUNT OF LEAD WAS PLACED BEHIND THE GENERATOR. THE CONNECTOR PIN APPEARED TO BE FULLY INSERTED. THE FILTER FEED-THRU WIRES APPEARED TO BE INTACT. THE LEAD ALSO APPEARED TO BE INTACT AT THE CONNECTOR PIN. THE TREATING NEUROLOGIST REFERRED THE PT FOR REVISION BUT PT DOES NOT WANT TO ADDRESS HER VNS ISSUE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 009157

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR