BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3931426 · Received June 26, 2014

    Report

    Report Number
    1627487-2014-01423
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 7, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL #S: 1627487-12192011-003-R, 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S EXPERIENCING UNCOMFORTABLE SHOCKING SENSATIONS WITH STIMULATION ON, AT THE RIGHT LOWER END OF THE BUTTOCKS AND IPG SITE. REPROGRAMMING WAS PERFORMED TO NO AVAIL. FOLLOW-UP IDENTIFIED X-RAYS WERE NORMAL AND THE ISSUE IS STILL PRESENT DAILY. THE NEXT COURSE OF ACTION IS UNDETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373134 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2793291

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other