BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENZA

    MDR report key: 7042997 · Received November 17, 2017

    Report

    Report Number
    3008514029-2017-00326
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 13, 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 EXPLANTED BUT WAS NOT RETURNED. THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND NO NON-CONFORMITIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT INDICATED THAT THE DEVICE WAS PROACTIVELY EXPLANTED DUE TO A WOUND HEALING ISSUE. THE CULTURE REPORT RESULTS FOR THE INITIAL REPORT OF INFECTION WAS NEGATIVE AND THE PATIENT DID NOT HAVE AN INFECTION. IT WAS NOTED THAT THE PATIENT HAS A HISTORY OF (B)(6) FROM A PREVIOUS KNEE REPLACEMENT SURGERY. 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 FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WAS HOSPITALIZED AND PROVIDED WITH IV ANTIBIOTICS. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821053 SENZA NEVRO SENZA LGW NEVRO CORPORATION NIPG1500 9440249 00813426020015

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other