BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENZA

    MDR report key: 7217609 · Received January 24, 2018

    Report

    Report Number
    3008514029-2018-00075
    Event Type
    Death
    Date Received
    January 24, 2018
    Date of Event
    January 24, 2017
    Report Date
    January 24, 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 RETURNED TO NEVRO FOR INVESTIGATION. THE MANUFACTURING RECORDS WERE REVIEWED AND NO NON-CONFORMITIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NEVRO BY THE PATIENT'S FAMILY THAT THE PATIENT HAD PASSED AWAY ABOUT SIX MONTHS AFTER IMPLANT. PRIOR FOLLOW UP INDICATED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. NEVRO HAD ATTEMPTED TO OBTAIN A MEDICAL ASSESSMENT FROM THE IMPLANTING PHYSICIAN BUT NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60406 SENZA NEVRO SENZA LGW NEVRO CORPORATION NIPG1500 9437381 00813426020015

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death