BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1083205 · Received July 24, 2008

    Report

    Report Number
    1644487-2008-01661
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS PATIENT WAS SCHEDULED FOR SURGERY TO REPLACE THE GENERATOR DUE TO END OF SERVICE. THE PHYSICIAN WAS NOT ABLE TO COMMUNICATE WITH THE DEVICE PRIOR TO SURGERY TO VERIFY END OF SERVICE, HOWEVER, A BATTERY LIFE CALCULATION PERFORMED WITH THE AVAILABLE PROGRAMMING HISTORY AND THE RESULT SUPPORTED THE END OF SERVICE CLAIM. THE SURGEON REVIEWED X-RAYS PRIOR TO SURGERY AND THERE WERE NO LEAD DISCONTINUITIES VISUALIZED ON THE X-RAYS. DURING SURGERY, WHEN A NEW GENERATOR WAS CONNECTED TO THE EXISTING LEAD AND A LEAD TEST WAS PERFORMED, HIGH LEAD IMPEDANCE RESULTED. THE TEST WAS REPEATED AFTER REMOVING AND REINSERTING THE LEAD PIN, AND RETIGHTENING THE SET SCREW WITH THE SAME RESULT. THERE WAS NO REPORT OF TRAUMA, MANIPULATION OR ANY OTHER EVENT THAT MAY HAVE CAUSED A PROBLEM WITH THE LEAD. THE SURGEON DID NOT VISUALIZE ANY PROBLEM WITH THE LEAD DURING SURGERY. THE SURGEON THEN REMOVED THE EXISTING PROBLEMATIC LEAD AND IMPLANTED A NEW DEVICE. THE EXPLANTED LEAD AND GENERATOR HAVE BEEN RETURNED TO MANUFACTURER AND ANALYSIS IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 6559

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR