BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8745714 · Received June 28, 2019

    Report

    Report Number
    3010309840-2019-00215
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 27, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT DURING A LAMINECTOMY PROCEDURE OF THE PERMANENT PADDLE LEAD IMPLANT, THE PATIENT EXPERIENCED DEFICIT IN THE RIGHT LEG. THE LEAD WAS RE-POSITIONED WITH CONTINUED DEFICIT TO PATIENT'S RIGHT LEG. SUBSEQUENTLY, THE LEAD WAS REMOVED AND THE PROCEDURE WAS ABORTED. FOLLOW-UP WAS PERFORMED AND THE PATIENT WAS ABLE TO MOVE ALL LIMBS AND THE PHYSICIAN EXPECTS A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537616 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 3101-60

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other