BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8633462 · Received May 22, 2019

    Report

    Report Number
    3010309840-2019-00208
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 22, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT DID NOT RECEIVE ANY STIMULATION DURING INTRA-OP TESTING OF THE TRIAL CABLE. DURING SURGERY, THE TRIAL CABLE WAS TESTED AND THE LEAD WAS RE-POSITIONED WITH CONTINUED IMPEDANCE ISSUES. SUBSEQUENTLY, THE LEAD WAS REPLACED AND THE PATIENT IS RECEIVING STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425772 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1124-60T W4559554

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention