BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3960633 · Received July 21, 2014

    Report

    Report Number
    1627487-2014-26578
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 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: 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, AT THE PATIENT'S IPG INCISION SITE LOCATED IN HIS RIGHT FLANK THERE WAS A LESION IN THE CENTER THAT WOULD NOT HEAL AND WAS DRAINING. CULTURES WERE TAKEN AND THE RESULTS WERE NEGATIVE FOR INFECTION, HOWEVER; THE PATIENT WAS ON AN EXTENDED COURSE OF ANTIBIOTICS PRIOR TO THE CULTURES. THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 WHERE THE IPG SITE WAS OPENED AND THE WOUND CLEANED AND THERE WAS EXTENSIVE AMOUNT OF COLORED DRAINAGE PRESENT. THE IPG POCKET WAS WASHED AND THE IPG WAS SOAKED IN BETADINE AND ANTIBIOTIC POWDER WAS POURED INTO THE IPG SITE PRIOR TO THE WOUND BEING CLOSED. FURTHER FOLLOW UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426651 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4562679

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other SCS LEAD: MODEL 3228| IMPLANT: