BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8635622 · Received May 23, 2019

    Report

    Report Number
    3010309840-2019-00209
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    April 24, 2019
    Report Date
    May 22, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT DURING IMPLANT OF A TRIAL LEAD, THE PHYSICIAN NOTICED THE STYLET HAD PROTRUDED THROUGH THE DISTAL END OF LEAD WHILE SWITCHING OUT THE STYLETS. A NEW LEAD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431626 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1121-60T W4562958

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other