BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3013944 · Received March 20, 2013

    Report

    Report Number
    1644487-2013-00746
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 19, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE.X-RAYS REVIEWED BY THE MANUFACTURER, A GROSS LEAD DISCONTINUITY WAS VISUALIZED.DEVICE FAILURE IS LIKELY BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT HIGH IMPEDANCE WAS SEEN DURING NORMAL MODE AND SYSTEM DIAGNOSTICS ON (B)(6) 2013. THE PATIENT HAD NOT BEEN EXPERIENCING AN INCREASE IN SEIZURES, BUT THE DOCTOR THOUGHT THIS WAS IRRELEVANT BECAUSE THE PATIENT HAD BEEN A NON-RESPONDER. THE PATIENT WAS PREVIOUSLY SEEN IN (B)(6) 2012, AND EVERYTHING WAS NORMAL. THE PATIENT'S SETTINGS WERE PROVIDED. THE DEVICE WAS DISABLED ON (B)(6) 2013. THERE WAS NO PATIENT MANIPULATION OR TRAUMA. X-RAYS WERE RECEIVED AND REVIEWED. 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 ACUTE ANGLE WAS FOUND, BUT A LEAD BREAK IN THE LEAD BODY WAS VISIBLE AT THE LEVEL OF THE 1ST-2ND RIB. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115165 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 2620

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR