BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 8424143 · Received March 15, 2019

    Report

    Report Number
    3010309840-2019-00172
    Event Type
    Death
    Date Received
    March 15, 2019
    Date of Event
    February 11, 2019
    Report Date
    March 14, 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 PASSED AWAY (B)(6) 2019 DUE TO MYOCARDIAL INFARCTION, UNRELATED TO THE DEVICE/THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218073 ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death