BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENZA

    MDR report key: 7328765 · Received March 9, 2018

    Report

    Report Number
    3008514029-2018-00163
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    February 6, 2018
    Report Date
    March 9, 2018
    Manufacturer
    NEVRO CORPORATION
    Product Code
    LGW
    UDI-DI
    00813426020015
    PMA / PMN Number
    P130022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EXPLANTED. THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND NO NON-CONFORMITIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NEVRO THAT A PATIENT HAD DEVELOPED A POSSIBLE INFECTION AND WAS HOSPITALIZED. NEVRO HAD ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169757 SENZA NEVRO SENZA LGW NEVRO CORPORATION NIPG1500 9438154 00813426020015

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other