BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8600918 · Received May 10, 2019

    Report

    Report Number
    3010309840-2019-00205
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    February 26, 2019
    Report Date
    May 10, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED PAIN AT THE STIMULATOR POCKET SITE AND A LACK OF THERAPEUTIC EFFECT TO THE LOWER BACK. MULTIPLE RE-PROGRAMMING WAS PERFORMED WITH NO SUCCESS. SUBSEQUENTLY, THE STIMULATOR AND LEADS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391771 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention