BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3082271 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-15506
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 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 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

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING DISCOMFORT, PAIN, AND SORENESS AT HIS IPG SITE. THE IPG IS IMPLANTED ALONG THE PATIENT'S BELT LINE. THE PATIENT STATED HE IS ABLE TO GRAB THE IPG AND FEEL IT FLOATING IN THE POCKET. THE PATIENT HAS DECREASED THE AMOUNT THEY ARE USING AND CHARGING THE SCS SYSTEM, BUT THE SORENESS STILL PERSISTS. PATIENT WILL CONSULT WITH HIS PHYSICIAN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163309 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3772670

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS LEAD, MODEL 3228| IMPLANT DATE: