BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 9560919 · Received January 7, 2020

    Report

    Report Number
    3010309840-2020-00244
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    November 26, 2019
    Report Date
    January 7, 2020
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE STIMULATOR AND LEAD WERE EXPLANTED DUE TO AN MRI. THERE WAS NO ISSUE WITH THE DEVICE. THE DEVICE WAS WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19785 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2412

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention