BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENZA

    MDR report key: 7043488 · Received November 17, 2017

    Report

    Report Number
    3008514029-2017-00319
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 31, 2017
    Report Date
    November 17, 2017
    Manufacturer
    NEVRO CORPORATION
    Product Code
    LGW
    UDI-DI
    00813426020022
    PMA / PMN Number
    P130022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT USED AND WAS NOT RETURNED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO NON-CONFORMITIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NEVRO THAT DURING AN IMPLANT PROCEDURE FOR A PERCUTANEOUS LEAD, THE PHYSICIAN HAD ENCOUNTERED SCAR TISSUE. WHEN THE LEAD WAS RETRACTED, THE INSERTION NEEDLE SLICED THE LEAD AND A CONTACT HAD BROKEN OFF. THE BROKEN CONTACT WAS LEFT IN SITU. THE PHYSICIAN WAS NOT CONCERNED AND THERE ARE NO PLANS FOR RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820865 SENZA NEVRO SENZA LGW NEVRO CORPORATION LEAD1058-50B 94404911 00813426020022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Other