BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENZA

    MDR report key: 7187998 · Received January 12, 2018

    Report

    Report Number
    3008514029-2018-00034
    Event Type
    Injury
    Date Received
    January 12, 2018
    Date of Event
    December 24, 2016
    Report Date
    January 12, 2018
    Manufacturer
    NEVRO CORPORATION
    Product Code
    LGW
    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 EXPLANTED BUT WAS NOT RETURNED. 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 ACQUIRED AN INFECTION. THE PATIENT WAS HOSPITALIZED AND TREATED WITH ORAL ANTIBIOTICS. THE PATIENT HAS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29777 SENZA NEVRO SENZA LGW NEVRO CORPORATION NIPG1500 9435807

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other