BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8496482 · Received April 9, 2019

    Report

    Report Number
    3010309840-2019-00185
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 11, 2019
    Report Date
    April 9, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT DUE TO THE PLACEMENT OF THE ORIGINAL LEAD. SUBSEQUENTLY, A REVISION WAS PERFORMED AND THE LEAD WAS REPLACED AND REPOSITIONED TO A NEW AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287541 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 3101-60 W3442620

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention