BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1973648 · Received January 18, 2011

    Report

    Report Number
    1644487-2011-00076
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 20, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT HAD HIGH LEAD IMPEDANCE AT AN OFFICE VISIT. THE PATIENT MAY HAVE CAUSED TRAUMA BY STRETCHING AND REACHING WHEN WORKING ON A CAR PER THE REPORTER. THE VNS WAS DISABLED. X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER. NO OBVIOUS LEAD BREAKS WERE NOTED, BUT THE LEAD PIN WAS FULLY INSERTED INTO THE GENERATOR HEADER, RULING OUT A PIN ISSUE; A LEAD FRACTURE IS SUSPECTED. THE PATIENT LATER HAD VNS LEAD AND GENERATOR REPLACEMENT SURGERY PERFORMED. ATTEMPTS FOR FURTHER INFORMATION AND RETURN OF THE EXPLANTED DEVICES ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 2084

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR