BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 9413357 · Received December 4, 2019

    Report

    Report Number
    3010309840-2019-00243
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 4, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REFERENCE NUMBER (B)(4). THE DEVICE HISTORY REVIEW (DHR) WAS REVIEWED AND NO ANOMALIES WERE NOTED. ALL DEVICES ARE 100% TESTED AT THE TIME OF MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED RIGHT HEEL PAIN FOLLOWING A TRIAL LEAD IMPLANT. SUBSEQUENTLY, THE TRIAL LEADS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204147 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 1124-60T W4871327

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention