BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIOPOLAR LEAD

    MDR report key: 663432 · Received October 7, 2005

    Report

    Report Number
    1644487-2005-00652
    Event Type
    Malfunction
    Date Received
    October 7, 2005
    Report Date
    September 7, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PATIENT UNDERWENT NCP SYSTEM REPLACEMENT SURGERY DUE TO SUSPECTED LEAD BREAK. IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE AN INCREASE IN SEIZURE ACTIVITY APPROXIMATELY FOUR MONTHS PRIOR TO NCP SYSTEM REPLACEMENT SURGERY. DEVICE DIAGNOSTIC TESTING PERFORMED TWO MONTHS PRIOR TO NCP SYSTEM REPLACEMENT SURGERY RESULED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7), INDICATING POSSIBLE DEVICE MALFUNCTION. DEVICE DIAGNOSTIC TESTING PERFORMED ON THE DAY OF REPLACEMENT SURGERY (PRIOR TO REPLACEMENT) ALSO YIELDED HIGH LEAD IMPEDANCE RESULTS (DC-DC CODE 7 AND LIMIT). THE ELECTIVE REPLACEMENT INDICATOR WAS NO, RULING OUT GENERATOR BATTERY END OF LIFE AS A POSSIBLE CAUSE OF THE HIGH LEAD IMPEDANCE TEST RESULTS. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY AFFECT DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIOPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 4920

    Patients

    Seq Age Sex Outcome Treatment
    1