BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3182118 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-03821
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 21, 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2013-03827. IT WAS REPORTED THE PATIENT WAS EXPERIENCING FLANK, ABDOMEN AND CHEST PAIN WHILE USING SYSTEM STIMULATION WHICH WOULD RESOLVE APPROXIMATELY A WEEK AFTER TURNING STIMULATION OFF. SUBSEQUENTLY, EXPLORATORY SURGICAL INTERVENTION WAS TAKEN AND THE PHYSICIAN FOUND BLOOD AND FLUID INSIDE THE SILICONE OF THE SCS LEAD AND THE SCS IPG HEADER. SUBSEQUENTLY, THE SCS LEAD AND SCS IPG WERE EXPLANTED AND REPLACED WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272132 EON MINI SCS IPG LGW ST. JUDE MEDICAL, NEUROMODULATION 3788 3881585

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other