BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4112622 · Received September 10, 2014

    Report

    Report Number
    1627487-2014-02635
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 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

    EVALUATION CODES: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORD REVIEWED FOUND NO NON-CONFORMANCES. 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

    DEVICE 1 OF 2 REFERENCE MFR REPORT: 1627487-2014-02636. THE PATIENT RECEIVED TWO SCS LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT HIS SCS LEAD SURGICAL INCISION SITE. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. HOWEVER, A FEW DAYS LATER THE PATIENT WENT TO THE ER WITH PUS AT THE LEAD SURGICAL SITE AND REDNESS AT HIS SCS IPG POCKET. THE PATIENT WAS HOSPITALIZED AND GIVEN IV ANTIBIOTICS. CULTURES TAKEN INDICATED THE INFECTION WAS CELLULITIS GRANULOMA. FOLLOW-UP IDENTIFIED THE PATIENT'S ENTIRE SCS SYSTEM WAS REMOVED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559889 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4393081

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR SCS ANCHOR, MODEL: 1194 (X2)| IMPLANT DATE: