BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 612090 · Received November 5, 2004

    Report

    Report Number
    1644487-2004-00963
    Event Type
    Malfunction
    Date Received
    November 5, 2004
    Report Date
    October 7, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT NCP SYSTEM REPLACEMENT DUE TO SUSPECTED LEAD BREAK. IT WAS ALSO REPORTED THAT DEVICE DIAGNOSTIC TESTING PRIOR TO NCP SYSTEM REPLACEMENT RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7) INDICATING POSSIBLE DEVICE MALFUNCTION. DURING THE SURGERY, SURGEON IDENTIFIED THAT THE LEAD WAS BROKEN AND WAS COVERED WITH A HARD DRY YELLOW-CLEAR SUBSTANCE. FURTHER FOLLOW-UP REVEALED THAT THE HIGH LEAD IMPEDANCE READING WAS RESOLVED WITH NCP SYSTEM REPLACEMENT. NEUROLOGIST INDICATED THAT THE PT IS DOING GOOD SINCE GENERATOR REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 27779C

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR