BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2771975 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-12193
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    August 7, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE 1 OF 4. REFERENCE MFR REPORT # 1627487-2012-12194, 12195, 12196. THE PATIENT REPORTED HE HAD SEVERE PAIN, SWELLING AND REDNESS IN HIS RIGHT LOWER LEG TWO WEEKS FOLLOWING THE IMPLANT SURGERY. THE PATIENT REPORTEDLY WAS HOSPITALIZED AND TREATED WITH LOVENOX AND COUMADIN FOR DEEP VEIN THROMBOSIS. THE SJM TM REPORTED ON (B)(6) 2012, THE PATIENT HAS MADE A FULL RECOVERY. THE PATIENT HAS THE STIMULATION ON AND GETTING GOOD COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3738710

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R SCS ANCHOR, MODEL: 1192 (2)| IMPLANT DATE: