BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3252189 · Received July 25, 2013

    Report

    Report Number
    1627487-2013-06663
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 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 WAS REPORTED THE PT IS HAVING DIFFICULTY CHARGING AND COMMUNICATING WITH HER IPG. THE PT STATED THE HER IPG SEEMS TO BE SLANTED INSIDE THE POCKET. AN SJM REPRESENTATIVE MET WITH THE PT AND CONFIRMED THE IPG IS ANGLED WHICH IS MAKING IT DIFFICULT TO COMMUNICATE. FOLLOW-UP IDENTIFIED THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2013 AND HER IPG WAS REPOSITIONED INSIDE THE POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347721 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3989094

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other SCS LEAD: MODEL 3219| IMPLANTED: