BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2171348 · Received July 18, 2011

    Report

    Report Number
    2171348
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    May 20, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A SUCCESSFUL IMPLANTATION OF ANS NEUROSTIM SPINAL CORD STIMULATOR (SCS) ~3 YEARS AGO. THIS SCS WAS NOTED TO HAVE A FAILURE AFTER 2 YEARS OF IMPLANTATION. PATIENT RETURNED TO SURGERY RECENTLY FOR REPLACEMENT OF SCS GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ADVANCED NEUROMODULATION SYSTEMS INC. 3788 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R NO OTHER THERAPIES