BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE CORPORATION SENZA PULSE IPG GENERATOR

    MDR report key: 7087029 · Received December 4, 2017

    Report

    Report Number
    MW5073777
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 17, 2017
    Report Date
    December 1, 2017
    Manufacturer
    NEVRO CORPORATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH LUMBAR RADICULOPATHY, POST LUMBAR LAMINECTOMY SYNDROME UNDERWENT IMPLANTATION OF SPINAL CORD STIMULATOR WITH 2 NEURAL STIMULATOR LEADS AND PULSE GENERATOR. INITIALLY PT RESPONDED WELL TO SPINAL CORD STIMULATOR IMPLANT, BUT LOST COVERAGE DUE TO STIMULATOR MALFUNCTION. PT UNDERWENT SECOND SURGERY IN WHICH THE PULSE GENERATOR WAS REMOVED AND REPLACED. THE ORIGINAL LEADS PLACED WERE NOT CHANGED, AND PT CONFIRMED APPROPRIATE COVERAGE BY STIMULATOR PRIOR TO LEAVING THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859935 DEVICE CORPORATION SENZA PULSE IPG GENERATOR NERVO SENZA PULSE IPG GENERATOR, STIMULATOR, SPINAL-CORD LGW NEVRO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention