BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1230464 · Received November 7, 2008

    Report

    Report Number
    1644487-2008-02613
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 16, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WOULD BE UNDERGOING REVISION SURGERY DUE TO A LEAD FRACTURE. AT FOLLOW UP WITH THE PATIENT, TREATING NEUROLOGIST REVEALED THAT THE EVENT WAS DIAGNOSED AFTER THE PATIENT RECEIVED A HIGH LEAD IMPEDANCE WARNING ON SYSTEM DIAGNOSTICS AND ADDED THAT THE PATIENT HAD MADE COMPLAINTS OF "THROAT CLEARING" PRECEDING THESE RESULTS. DURING THE SURGERY, IT WAS REVEALED THAT THE PATIENT'S LEAD HAD DEVELOPED EXCESSIVE AMOUNTS OF SCAR TISSUE ON THE ELECTRODES. THE SURGEON ATTRIBUTED THE HIGH IMPEDANCE RESULTS TO THE AMOUNT OF SCAR TISSUE THAT WAS AROUND THE NERVE AS A LEAD BREAK WAS NOT VISUALIZED DURING SURGERY. DURING THE SURGERY, THE SCRUB NURSE REPORTEDLY BEGAN TO INSPECT THE EXPLANTED PORTIONS OF LEAD AND PROCEEDED TO PULL OFF THE LEADS INSULATION AND CUT IT IN HALF. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200487

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR