BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3221759 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-15928
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-15927. IT WAS REPORTED THE PT WAS NOT RECEIVING STIMULATION IN HIS LOWER BACK AND BILATERAL LOWER EXTREMITIES. DIAGNOSTIC TESTING REVEALED LOW IMPEDANCE READINGS. X-RAYS WERE TAKEN AND INDICATED THE PT'S MODEL 3186 LEAD HAD MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312691 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3910840

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192| SCS LEAD: MODEL 3163