BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8866465 · Received August 6, 2019

    Report

    Report Number
    3010309840-2019-00227
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 6, 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 AN INFECTION AT THE POCKET SITE DUE TO POOR POST-SURGICAL CARE. SUBSEQUENTLY, THE STIMULATOR WAS EXPLANTED AND REPLACED TO ANOTHER LOCATION. THERE WAS NO ISSUE WITH THE DEVICE/THERAPY. THE INFECTION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660036 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention