BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 7399452 · Received April 5, 2018

    Report

    Report Number
    3010309840-2018-00077
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    March 8, 2018
    Report Date
    April 5, 2018
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NUVECTRA THAT ON (B)(6) 2016, THE PATIENT WAS UNABLE TO RECEIVED STIMULATION DUE TO CHARGING ISSUES WITH THE STIMULATOR. ON 10 NOVEMBER 2016, A NUVECTRA REPRESENTATIVE MET WITH THE PATIENT AND RESOLVED THE CHARGING ISSUES WITH TROUBLESHOOTING. THE PATIENT RECEIVED STIMULATION. ON (B)(6) 2018, IT WAS REPORTED TO NUVECTRA THAT THE STIMULATOR WAS EXPLANTED DUE TO THE ONGOING CHARGING ISSUES. THE PATIENT IS RECEIVING STIMULATION FOLLOWING THE STIMULATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244252 ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION 2408

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention