BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3810807 · Received April 28, 2014

    Report

    Report Number
    1627487-2014-25321
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    March 31, 2014
    Report Date
    July 20, 2015
    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

    RESULTS: THE REPORTED ISSUE OF PAIN AT THE IPG SITE WAS NOT CONFIRMED. AS RECEIVED, THE IPG WAS RESPONSIVE AND COMMUNICATED WITH LAB UTILITIES. THE DEVICE WAS TESTED TO MANUFACTURING SPECIFICATIONS USING AUTO MATED TEST EQUIPMENT AND PASSED ALL TESTS. PROGRAMMING THE IPG WITH AGGRESSIVE SETTINGS DID NOT DISPLAY ANY ANOMALOUS OUTPUTS WHEN MONITORED ON AN OSCILLOSCOPE. THE MAGNET FEATURE FUNCTIONED AS INTENDED. NO VISUAL OR FUNCTIONAL ANOMALY WAS OBSERVED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. THE RETURNED IPG DISPLAYED NORMAL DEVICE CHARACTERISTICS. 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.

    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.

    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 IS EXPERIENCING PERSISTENT PAIN AT THE IPG SITE AND THE IPG HAS MOVED. ADDITIONALLY, THE PT REPORTED FALLING MULTIPLE TIMES PER DAY. IN TURN, THE PHYSICIAN WILL TAKE X-RAYS AND POSSIBLY REFER THE PT TO A SURGEON FOR CONSULT.

    Description of Event or Problem · 1

    FOLLOW-UP REVEALED THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE IPG. ADDITIONALLY, IT WAS NOTED THE PHYSICIAN ATTRIBUTES THE PATIENT'S PAIN TO A PREVIOUS SPINAL CORD INJURY PRIOR TO THE IMPLANTATION OF THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254413 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 3856855

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other SCS LEAD: MODEL 3225| IMPLANT DATE: