BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8902705 · Received August 16, 2019

    Report

    Report Number
    3010309840-2019-00230
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 19, 2019
    Report Date
    August 16, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED A STAPH INFECTION DUE TO AN OPEN POCKET WOUND. SUBSEQUENTLY, THE STIMULATOR AND LEAD WERE EXPLANTED AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694387 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention