BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8571870 · Received May 1, 2019

    Report

    Report Number
    3010309840-2019-00199
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 2, 2019
    Report Date
    May 1, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Product Problem
    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 WAS NOT RECEIVING PAIN RELIEF ON THE RIGHT SIDE OF THE BODY, JUST TO THE LEFT SIDE. X-RAYS WERE PERFORMED AND REVEALED PROPER LEAD PLACEMENT. THE PATIENT ELECTED TO KEEP THE ORIGINAL STIMULATOR IMPLANTED DUE TO RECEIVING STIMULATION TO THE LOWER EXTREMITIES AND OPTED TO HAVE ANOTHER STIMULATOR IMPLANTED TO ADDRESS THE RIGHT FOOT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360955 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention