BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 7138564 · Received December 21, 2017

    Report

    Report Number
    3010309840-2017-00051
    Event Type
    Death
    Date Received
    December 21, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 19, 2017
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT HAD GREAT PAIN RELIEF WITH THE TRIAL LEADS. FOLLOWING THE REMOVAL OF THE TRIAL LEADS, THE PATIENT PASSED AWAY FIVE DAYS POST EXPLANT. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918470 ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1124-60T W3929342

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death