BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8701597 · Received June 14, 2019

    Report

    Report Number
    3010309840-2019-00210
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 6, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT. MULTIPLE REPROGRAMMING WAS PERFORMED WITH NO SUCCESS. THE PHYSICIAN CUT THE LEAD AND DID NOT REMOVE THE PROXIMAL END OF THE LEAD FROM THE HEADER AND THERE ARE NO PLANS TO REMOVE REMAINING PORTION OF LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495589 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1084-75 W4023436

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention