BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALGOVITA-SPINAL CORD STIMULATION

    MDR report key: 6942647 · Received October 11, 2017

    Report

    Report Number
    3010309840-2017-00039
    Event Type
    Death
    Date Received
    October 11, 2017
    Date of Event
    September 18, 2017
    Report Date
    October 11, 2017
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT A PATIENT DEATH OCCURRED FOUR DAYS POST TRIAL IMPLANT. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719491 ALGOVITA-SPINAL CORD STIMULATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1124-45T W3724387

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death