BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4112671 · Received September 10, 2014

    Report

    Report Number
    1627487-2014-06270
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    February 2, 2013
    Report Date
    August 13, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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: 1627487-2014-06271. INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY, INDICATED THE PATIENT ALLEGES THE FOLLOWING ISSUES: THE PATIENT EXPERIENCED BURNING WHILE CHARGING AND DISCOMFORT DUE TO OVER-STIMULATION. THE PATIENT REPORTED HIS SCS IPG WAS REMOVED IN (B)(6) 2013 AND HIS SCS LEAD WAS REMOVED ON (B)(6) 2013. THE PATIENT STATES HIS SCS SYSTEM CAUSED HIM DISCOMFORT (BURNING, STINGING, AND PINS AND NEEDLES) IN THE AREA WHERE DEVICE WAS IMPLANTED. ADDITIONAL INFORMATION IS NEEDED TO CLARIFY THE NATURE OF THE PATIENT'S ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(4) 2014, AND THE PATIENT'S SCS SYSTEM WAS NOT EVALUATED BY AN SJM REPRESENTATIVE TO VERIFY AND/OR TROUBLESHOOT ANY OF THE REPORTED ISSUES PRIOR TO EXPLANT. A REVIEW OF THE PATIENT'S MEDICAL CHART IDENTIFIED THE PATIENT UNDERWENT SCS PLACEMENT IN (B)(6) 2013, DUE TO NECK PAIN FROM A TRACTOR INJURY AND BACK PAIN FROM FALLING OFF A BULLDOZER. ON (B)(6) 2013, THE PATIENT COMPLAINED OF INEFFECTIVE PAIN RELIEF FROM STIMULATION ALONG WITH ADDITIONAL NEW PAIN. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE AND PROLOTHERAPY AND PHYSICAL THERAPY WERE RECOMMENDED TO THE PATIENT ON (B)(6) 2013, THE PATIENT COMPLAINED OF BACK, LEG, NECK AND ARM PAIN AND WANTED HIS SCS SYSTEM REMOVED. ON (B)(6) 2013, HE UNDERWENT SURGICAL REMOVAL OF HIS SCS IPG. THE PHYSICIAN WAS UNABLE TO REMOVE THE PATIENT'S SCS LEAD DUE TO SCAR TISSUE. ON (B)(6) 2013, THE PATIENT COMPLAINED OF BILATERAL THORACIC PAIN (B)(6). THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR REMOVAL OF HIS SCS LEAD. ON (B)(6) 2013, HE UNDERWENT REMOVAL OF THE SCS LEAD. DUE TO THE NATURE OF LITIGATION, THESE ALLEGATIONS CANNOT BE CONFIRMED OR REJECTED. SJM RECEIVED 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 REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559582 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3867385

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other