BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 612067 · Received October 15, 2004

    Report

    Report Number
    1644487-2004-00912
    Event Type
    Malfunction
    Date Received
    October 15, 2004
    Report Date
    September 17, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT UNDERWENT NCP SYSTEM REPLACEMENT DUE TO APPARENT LEAD BREAK. DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT PRIOR TO NCP SYSTEM REPLACEMENT RESULTED IN HIGH LEAD IMPEDANCE (DC-DC CODE UNK), INDICATING POSSIBLE DEVICE MALFUNCTION. EPILEPTOLOGIST INDICATED THAT THE PT DID NOT SUFFER ANY INJURY OR TRAUMA THAT COULD HAVE DAMAGED THE NCP SYSTEM. X-RAYS REVIEWED BY EPILEPTOLOGIST IDENTIFIED A LEAD BREAK APPROX 4.5CM SUPERIOR TO THE GENERATOR. EPILEPTOLOGIST INDICATED THAT THE PT'S SEIZURES ARE CONTROLLED AND THE PT IS STABLE SINCE NCP SYSTEM REPLACEMENT. EPILEPTOLOGIST REPORTED THAT THE GENERATOR WAS REPLACED PROPHYLACTICALLY. NO ADVERSE EVENT WAS REPORTED IN CONJUNCTION WITH THE HIGH LEAD IMPEDANCE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 26423C

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR