BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8137332 · Received November 21, 2018

    Report

    Report Number
    8137332
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    October 18, 2018
    Report Date
    October 22, 2018
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WITH THE HELP OF THE SPINAL CORD STIMULATOR DEVICE REP THE IPG OF THE SPINAL CORD STIMULATOR WAS INTERROGATED AND THE INFO DOWNLOADED TO THE CONTROL DEVICE. AFTER DISCUSSING THE PT'S SYMPTOMS, THE SPINAL CORD STIMULATOR WAS THEN PROGRAMMED TO OBTAIN COMFORTABLE STIMULATION IN THE PT'S PAINFUL AREAS. GREATER THAN THREE PARAMETERS WERE ADJUSTED DURING THIS PROGRAMMING. HOWEVER, HE REPORTED THE AREAS OF PAIN WERE COVERED BUT HE WAS UNABLE TO OBTAIN ENOUGH PAIN RELIEF FROM THE VARIOUS PROGRAMS TRIALED. THE PT WAS THEN PLACED IN A FORWARD FLEXED POSITION AND THE BATTERY / IPG WAS DISCONNECTED. THE LEADS WERE REMOVED, TIP INTACT ON THE LEFT BUT THE RIGHT LEAD WAS FRAYED AND FIVE OF THE CONTACTS REMAINED LODGED IN THE PT. ALL OF THE CONTACTS WERE REMOVED ON THE LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937668 NUVECTRA CORPORATION SPINAL CORD STIMULATOR LGW NUVECTRA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention