BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3233542 · Received July 18, 2013

    Report

    Report Number
    1644487-2013-02064
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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

    ON (B)(6) 2013, IT WAS REPORTED THAT HIGH IMPEDANCE WAS SEEN ON. THE PHYSICIAN SUSPECTED INCOMPLETE PIN INSERTION OR FIBROSIS. THE OUTPUT CURRENT WAS LEFT AT 1.75 MA, BUT THE INTENSITY WAS DECREASED AND THE PULSEWIDTH WAS INCREASED FROM 250 USEC TO 500 USEC. X-RAYS WERE RECEIVED: AP CHEST AND NECK AND LATERAL CHEST X-RAYS SHOWED THAT THE GENERATOR APPEARS IN THE UPPER LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN WAS FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. PART OF THE LEAD WAS BEHIND THE GENERATOR. NO CLEAR LEAD BREAKS WERE FOUND IN THE PARTS OF THE LEAD THAT COULD BE ASSESSED. THE PRESENCE OF SHARP ANGLES CANNOT BE FULLY RULED OUT, AS THE UPPER PART OF THE LEAD, CLOSE TO THE ELECTRODES PLACEMENT ON THE VAGUS NERVE, APPEARS TO BE TWISTED IN THE AP VIEW. THE LATERAL VIEW THAT WAS RECEIVED HAD A CONTRAST AND BRIGHTNESS LEVEL THAT DID NOT PERMIT TO CONFIRM THAT THOSE TWISTS ARE SHARP BENDS. THE PATIENT WAS SEEN ON (B)(6) 2013, AND THE DEVICE WAS DISABLED. THERE WAS NO SUSPICION OF TRAUMA. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE

    Description of Event or Problem · 1

    SYSTEM DIAGNOSTICS RESULTS WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333832 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200936

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR