BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2890750 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-02890
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: 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 INFO 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 WAS ADMITTED TO THE HOSP FOR A SEROMA AND CELLULITIS AT HIS IPG SITE. THE PT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND A CULTURE WAS TAKEN. IT WAS REPORTED, THE PT HAD A SURGERY TO CLEAN OUT THE WOUND AND WAS DISCHARGED FROM THE HOSP SHORTLY AFTER THE PROCEDURE. F/U IDENTIFIED THE SITE IS HEALING AND THE DEVICE REMAINS IMPLANTED. CULTURE RESULTS REVEALED NO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3830694

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: