BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 549965 · Received April 15, 2004

    Report

    Report Number
    1644487-2004-00312
    Event Type
    Malfunction
    Date Received
    April 15, 2004
    Report Date
    March 16, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE DEVICE MALFUNCTION. X-RAY REVIEW BY NEUROLOGIST DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. THE PT HAD NOT SUFFERED ANY KNOWN INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM. LEAD BREAK IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 1839

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR LOT NO. 1989.| 06/30/2002, DATE OF MFG 01/23/2001, STERILIZATION| MODEL 101 NCP PULSE GENERATOR, EXPIR DATE