BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1040373 · Received May 6, 2008

    Report

    Report Number
    1644487-2008-01087
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 10, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROS 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 TO MANUFACTURER THAT THE VNS PT HAD A SUDDEN ONSET OF TISSUE VIBRATIONS IN THE THROAT, AND SEVERE HEADACHES. THE PT SUBSEQUENTLY FOLLOWED UP WITH THE TREATING PHYSICIAN AND BOTH A NORMAL MODE AND SYSTEM DIAGNOSTIC TEST WERE PERFORMED AND REVEALED HIGH LEAD IMPEDANCE, END OF SERVICE WAS SET TO NO. THERE WAS NO REPORT OF TRAUMA OR MANIPULATION OF THE DEVICE. X-RAYS WERE TAKEN AND SENT TO MANUFACTURER FOR REVIEW. REVIEW OF X-RAYS REVEALED NO OBVIOUS LEAD DISCONTINUITIES OR PIN INSERTION ISSUES THAT COULD BE CONTRIBUTING TO THE HIGH LEAD IMPEDANCE. ATTEMPTS TO OBTAIN ADD'L INFO FROM THE TREATING PHYSICIAN ARE UNDERWAY. REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009946

    Patients

    Seq Age Sex Outcome Treatment
    1