BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8701593 · Received June 14, 2019

    Report

    Report Number
    3010309840-2019-00212
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 10, 2019
    Report Date
    June 7, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED IMPEDANCE ISSUES. AN X-RAY WAS PERFORMED AND EXHIBITED THE LEAD HAD SEPARATED INTO TWO PIECES. FURTHER PROGRAMMING WAS PERFORMED WITH SUCCESS. THERE ARE NO PLANS TO REMOVE THE BROKEN LEAD AS THE PATIENT IS RECEIVING COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494558 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1124-60 W4186603

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other