BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENZA

    MDR report key: 7042986 · Received November 17, 2017

    Report

    Report Number
    3008514029-2017-00312
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    September 15, 2017
    Report Date
    November 17, 2017
    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 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 HEMATOMA FOLLOWING AN IMPLANT PROCEDURE. THE SITE WAS DRAINED AND THE DEVICE WAS NOT EXPLANTED. THE PATIENT HAS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820849 SENZA NEVRO SENZA LGW NEVRO CORPORATION NIPG1500 9440049 00813426020015

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other