BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENZA

    MDR report key: 7325456 · Received March 8, 2018

    Report

    Report Number
    3008514029-2018-00157
    Event Type
    Death
    Date Received
    March 8, 2018
    Date of Event
    April 13, 2017
    Report Date
    March 8, 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 FROM UNRELATED ISSUES ABOUT A YEAR AFTER IMPLANT. 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
    167378 SENZA NEVRO SENZA LGW NEVRO CORPORATION NIPG1500 9436595 00813426020015

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death