BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVECTRA CORPORATION

    MDR report key: 9333353 · Received November 17, 2019

    Report

    Report Number
    3010309840-2019-00239
    Event Type
    Injury
    Date Received
    November 17, 2019
    Date of Event
    October 4, 2019
    Report Date
    November 14, 2019
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REFERENCE NUMBER- (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED A SKIN EROSION AT THE POCKET SITE. SUBSEQUENTLY, THE STIMULATOR WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127875 NUVECTRA CORPORATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2408

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention