BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 8473699 · Received April 2, 2019

    Report

    Report Number
    3010309840-2019-00180
    Event Type
    Death
    Date Received
    April 2, 2019
    Date of Event
    March 4, 2019
    Report Date
    April 1, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT PASSED AWAY DUE TO GASTROINTESTINAL (GI) ISSUES AND INTERNAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266950 ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death