BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4253000 · Received November 12, 2014

    Report

    Report Number
    1627487-2014-26948
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ST. JUDE MED - 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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 PATIENT IS EXPERIENCING SWELLING AT HIS IPG SITE. FOLLOW UP INFORMATION IDENTIFIED THE SWELLING HAS IMPROVED AND THE PATIENT WAS DIAGNOSED WITH AN INFECTION AT THE IPG SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729741 EON MINI SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3788 4631608

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (3)| IMPLANT DATE:| SCS LEAD: MODEL 3169 (4)| IMPLANT DATE:| SCS EXTENSION: MODEL 3343 (2)