BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 7462424 · Received April 25, 2018

    Report

    Report Number
    3010309840-2018-00080
    Event Type
    Injury
    Date Received
    April 25, 2018
    Date of Event
    April 16, 2018
    Report Date
    April 25, 2018
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA ON 22 SEPTEMBER 2016 THAT THE PATIENT EXPERIENCED OVERSTIMULATION TOWARDS THE RIGHT OCCIPITAL HEAD. SUBSEQUENTLY, THE STIMULATOR WAS TURNED OFF DUE TO THE PATIENT EXPERIENCING MIGRAINES, CANCER, AND OTHER HEALTH ISSUES. ON (B)(6) 2018, IT WAS REPORTED TO NUVECTRA THAT THE STIMULATOR WAS EXPLANTED DUE TO THE ONGOING OVERSTIMULATION. THE PATIENT IS RECEIVING STIMULATION FOLLOWING THE STIMULATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300656 ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other