BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3123600 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-03659
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    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 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

    IT WS REPORTED THE PT IS EXPERIENCING HEATING AT HER SCS IPG POCKET SITE REGARDLESS OF STIMULATION; HOWEVER, THE HEATING IS WORSE WITHOUT STIMULATION. FOLLOW-UP IDENTIFIED THE SJM REPRESENTATIVE WAS ABLE TO CONFIRM AND CLARIFY THAT THE PT WAS NOT EXPERIENCING POCKET HEATING BUT WAS EXPERIENCING PAIN NEAR THE SCS IPG WHICH RESULTED AFTER THE PT FELL ON THE SCS IPG TWICE. THE SJM REPRESENTATIVE ALSO CONFIRMED THE PT'S SCS SYSTEM WAS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219330 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3735267

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANTED:| SCS LEAD: MODEL 3186 (2)| IMPLANTED: