BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 7421107 · Received April 11, 2018

    Report

    Report Number
    3010309840-2018-00079
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    February 23, 2018
    Report Date
    April 11, 2018
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT FOLLOWING TWO MONTHS POST PERMANENT IMPLANT. A NUVECTRA REPRESENTATIVE MET WITH THE PATIENT TO REPROGRAM THE DEVICE. SUBSEQUENTLY, THE PATIENT LATER MET WITH THE PHYSICIAN AND DECIDED TO REMOVE THE STIMULATOR AND LEAD. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264882 ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2408

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other