BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 8571869 · Received May 1, 2019

    Report

    Report Number
    3010309840-2019-00200
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 2, 2019
    Report Date
    May 1, 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 DURING A TRIAL LEAD IMPLANT, THE PHYSICIAN EXPERIENCED DIFFICULTY PLACING THE LEAD DUE TO THE PATIENT'S ANATOMY. AFTER MULTIPLE STYLET CHANGES, THE PHYSICIAN COULD NOT INSERT THE STYLET COMPLETELY INTO THE LEAD. EXAMINATION OF THE LEAD SHOWED THAT IT WAS FRACTURED AT THE CONTACT SITE. A NEW COMPACT LEAD WAS USED INSTEAD AND WAS ABLE TO BE PLACED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361267 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1121-60T W4585251

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other