BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8596955 · Received May 9, 2019

    Report

    Report Number
    3010309840-2019-00204
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 9, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Product Problem
    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 DURING IMPLANT OF THE PERMANENT LEADS, THE FIRST STYLET PROTRUDED THROUGH THE DISTAL END OF THE LEAD. THE SECOND STYLET WOULD NOT ADVANCE THROUGH THE SECOND LEAD. SUBSEQUENTLY, THE CASE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390606 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1124-60 W4519250

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention