BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8629310 · Received May 21, 2019

    Report

    Report Number
    3010309840-2019-00207
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    April 22, 2019
    Report Date
    May 21, 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 A SUBCUTANEOUS INFECTION. SUBSEQUENTLY, THE STIMULATOR AND LEAD WERE EXPLANTED. THE CAUSE OF THE INFECTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421229 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other