BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3900171 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-26447
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 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 AN 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'S WOUND IN HER BACK AT THE IPG SITE WAS OPEN AND DRAINING. FOLLOW UP INFORMATION IDENTIFIED THE IPG SITE WAS REVISED AND A NEW INCISION WAS MADE ABOVE THE CURRENT INCISION. A CULTURE WAS TAKEN AND WAS NEGATIVE. THE PHYSICIAN DID NOT SEE ANY SIGNS OF INFECTION. THE WOUND SITE WILL CONTINUE TO BE MONITORED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315089 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4434290

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS EXTENSION: MODEL 3383| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192