BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8587276 · Received May 7, 2019

    Report

    Report Number
    3010309840-2019-00202
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 8, 2019
    Report Date
    May 7, 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 PHYSICIAN EXPERIENCED DIFFICULTY WITH ACCESSING THE POSTERIOR AND USED SEVERAL NEEDLE ANGLES. THE LEADS WERE IMPLANTED AND CONNECTED TO THE STIMULATOR AND TESTED WITH IMPEDANCE ISSUES. MULTIPLE TROUBLESHOOTING WAS PERFORMED WITH NO SUCCESS. SUBSEQUENTLY, THE LEADS WERE REPLACED AND TESTED AGAIN WITH NO IMPEDANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382228 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1121-60 W4595278

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention