BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4080687 · Received July 24, 2014

    Report

    Report Number
    1627487-2014-08068
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    December 2, 2013
    Report Date
    June 2, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO 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 PATIENT WAS EXPERIENCING PAIN AT HER SCS IPG SITE FOR THE PAST SIX MONTHS. PATIENT WILL F/U WITH HER PHYSICIAN TO DETERMINE NEXT STEPS TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432941 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3382937

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other SCS ANCHOR, MODEL 1192 (2)| SCS LEAD, MODEL 3186 (2)| IMPLANT DATE:| IMPLANT DATE: