BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3960873 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-02516
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    August 8, 2013
    Report Date
    July 1, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 PT COMPLAINED OF EXPERIENCING AN UNCOMFORTABLE FEELING AT HER SCS IPG SITE. THE PT WAS INSTRUCTED TO TURN HER SCS SYSTEM OFF TO SEE IF THE FEELING WOULD SUBSIDE. HOWEVER, THE FEELING DID NOT SUBSIDE. THE PT WAS ADVISED TO CONTACT HER PHYSICIAN OR GO TO THE ER. FOLLOW UP ON (B)(6) 2013 IDENTIFIED THE PT'S ISSUE CONTINUES. THE PT WAS ATTEMPTING TO MEET WITH HER PHYSICIAN AND A SJM REP TO FURTHER EVALUATE THE ISSUE. ADDITIONAL INFO RECEIVED ON (B)(4) 2014 IDENTIFIED THE PT WAS GIVEN AN INJECTION FOR THE PAIN AT HER SCS IPG SITE. THE PT WAS ALSO ADVISED TO TURN HER STIMULATION THERAPY OFF FOR SIX HRS OR MORE TO SEE IF THE PAIN SUBSIDES. A SYSTEM DIAGNOSTICS REVEALED LOW IMPEDANCES. HOWEVER, THE PT REPORTED SHE WAS SATISFIED WITH HER STIMULATION. ADDITIONAL INFO RECEIVED ON (B)(4) 2014 IDENTIFIED THE PT REPORTS THE DISCOMFORT AT HER IPG SITE HAS BECOME PROGRESSIVELY WORSE. THE PT STATED SHE HAS USED LIDODERM PATCHES AND WILL TRY A COMPOUND PAIN CREAM. A SYSTEM DIAGNOSTICS AGAIN SHOWED LOW IMPEDANCES. THE PT IS RECEIVING EFFECTIVE STIMULATION THERAPY. THE PT'S CURRENT PHYSICIAN DOES NOT PLAN TO TAKE ANY SURGICAL INTERVENTION. BUT, THE PT PLANS TO RETURN TO THE IMPLANTING PHYSICIAN AND POSSIBLY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427284 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 3869035

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other IMPLANT DATE:| SCS LEAD: MODEL 1192 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)