BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPOLAR LEAD MOD 300

    MDR report key: 692786 · Received March 23, 2006

    Report

    Report Number
    1644487-2006-00160
    Event Type
    Other
    Date Received
    March 23, 2006
    Report Date
    February 24, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE DEVICE MALFUNCTION. THE ELECTIVE REPLACEMENT INDICATOR WAS NO RULING OUT GENERATOR BATTERY END OF LIFE AS A LIKELY CAUSE OF THE HIGH LEAD IMPEDANCE TEST RESULT. A REVIEW OF DEVICE PROGRAMMING HISTORY REVEALED THAT DEVICE DIAGNOSTIC TESTING HAS RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT) FOR AT LEAST THE PAST 10 MONTHS. THE PT UNDERWENT EXPLORATORY SURGERY. OPERATIVE NOTES FROM THE SURGERY INDICATE THAT THE LEAD PINS WERE DISCONNECTED FROM THE GENERATOR, CLEANED OFF, AND THEN RECONNECTED TO THE GENERATOR, AFTER WHICH DEVICE DIAGNOSTIC TESTING WAS WITHIN NORMAL LIMITS. THE GENERATOR WAS PUT BACK INTO THE PT AND THE PT WAS CLOSED. THE ACCEPTABLE DEVICE DIAGNOSTIC TESTING PERFORMED AFTER LEAD PIN REINSERTION INDICATES THAT THE MOST LIKELY CAUSE OF THE HIGH LEAD IMPEDANCE CONDITION WAS IMPROPER GENERATOR/LEAD CONNECTION. NO ADVERSE EVENT WAS REPORTED IN CONJUNCTION WITH THE HIGH LEAD IMPEDANCE CONDITION. THE CAUSE OF THE APPARENT GENERATOR/LEAD CONNECTION ISSUE IS NOT KNOWN; HOWEVER, USER ERROR AT TIME OF INITIAL IMPLANT SURGERY IS SUSPECTED AS IT IS LIKELY THAT A PROPER GENEATOR/LEAD CONECTION WAS NOT ACHIEVED AT THE TIME OF INITIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MOD 300 LYJ LYJ CYBERONICS, INC. 300-20 1791

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR