BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENZA

    MDR report key: 7217598 · Received January 24, 2018

    Report

    Report Number
    3008514029-2018-00097
    Event Type
    Injury
    Date Received
    January 24, 2018
    Date of Event
    February 23, 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 RETURNED TO NEVRO AND EXAMINED. THE INVESTIGATION CONCLUDED THE NEVRO SYSTEM HAD EXHIBITED NORMAL FUNCTIONALITY. THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND NO NON-CONFORMITIES WERE FOUND. BASED ON THE FUNCTIONAL TESTING AND RECORDS REVIEW RESULTS, THE PATIENT'S INFECTION WAS LIKELY DUE TO A PROCEDURAL ISSUE RATHER THAN DEVICE-RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NEVRO THAT A PATIENT HAD ACQUIRED AN INFECTION FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59808 SENZA NEVRO SENZA LGW NEVRO CORPORATION NIPG1500 9438017 00813426020015

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other