BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 612034 · Received July 23, 2004

    Report

    Report Number
    1644487-2004-00595
    Event Type
    Malfunction
    Date Received
    July 23, 2004
    Report Date
    June 25, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VNS PT UNDERWENT NCP SYSTEM REPLACEMENT SURGERY DUE TO RELENTLESS LEFT NECK PAIN. A VOLUNTARY MEDWATCH FORM INDICATED A PRODUCT PROBLEM WAS SUBMITTED TO MANUFACTURER FROM USER FACILITY. THE NATURE OF THE ALLEGED PRODUCT PROBLEM WAS NOT DESCRIBED. OPERATIVE NOTES FROM REPLACEMENT SURGERY INDICATE THAT THE PT UNDERWENT NCP SYSTEM REPLACEMENT SURGERY ELECTIVELY DUE TO REFRACTORY RELENTLESS NECK PAIN ASSOCIATED WITH THE DEVICE. BOTH THE GENERATOR AND LEAD (INCLUDING ELECTRODES) WERE EXPLANTED AND THE PT WAS REIMPLANTED WITH A NEW NCP SYSTEM. THE PT IS REPORTEDLY DOING WELL FOLLOWING NCP SYSTEM REPLACEMENT SURGERY. TREATING NEUROSURGEON INDICATED THAT SURGICAL TECHNIQUE DURING INITIAL NCP SYSTEM IMPLANT MAY HAVE CONTRIBUTED TO THE PT'S PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEADA LYJ CYBERONICS, INC. 300-20 736

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR