BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 300

    MDR report key: 1910125 · Received November 10, 2010

    Report

    Report Number
    1644487-2010-02528
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 11, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE WAS SHOWING AN INCREASE IN OHMS VALUE FROM 1916 OHMS ONE YEAR AGO TO 6583 OHMS RECENTLY. LEAD IMPEDANCE WAS OK ON DIAGNOSTICS, HOWEVER. REPORTER ALSO NOTED THAT THE END OF SERVICE PROJECTION WAS 7.7 YEARS REMAINING ON YEAR AGO AND NOW IS SHOWING 2.9 YEARS REMAINING. THE DEVICE OUTPUT CURRENT WAS TURNED DOWN TO PRESERVE BATTERY LIFE. IT WAS ALSO REPORTED THAT THE PT HAD A SERIOUS FALL WITH BROKEN LIMBS. X-RAYS WERE TAKEN AND REVIEWED BY THE MANUFACTURER. UPON REVIEW, THE POSITIVE ELECTRODE APPEARED TO BE BROKEN AND THE ELECTRODE PLACEMENT MAY BE OFF. NO OTHER ANOMALIES WERE NOTED. BASED ON THE X-RAY IMAGES PROVIDED, THE EXACT CAUSE OF THE INCREASED LEAD IMPEDANCE IS UNK; HOWEVER, THE BROKEN POSITIVE COIL AND ELECTRODE PLACEMENT MAY BE CONTRIBUTING FACTORS. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 300 LYJ CYBERONICS INC 300-20 12296C

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR