BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4091777 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-15633
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2014-15634, 15635. IT WAS REPORTED THE PT EXPERIENCED BURNING AT THE IPG SITE WHICH CEASED WHEN STIMULATION WAS TURNED OFF. ADDITIONALLY, THE PT EXPERIENCED PAIN IN HER LEG WITH STIMULATION ON AND OFF. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526453 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4294702

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other SCS ANCHOR, MODEL: 1192| IMPLANT DATE: