BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110860 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-13704
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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: 1627487-2013-13705 AND 1627487-2013-13706. THE PT REPORTED HER SCS SYS WAS EXPLANTED SOMETIME IN 2012. THE PT STATED THE SYS APPEARED TO BE FUNCTIONED PROPERLY; HOWEVER, SHE WAS NOT RECEIVING ADEQUATE PAIN RELIEF FROM THE STIMULATION EVEN AFTER MULTIPLE PROGRAMMINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202280 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3410795

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention EXPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192