BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3926344 · Received June 2, 2014

    Report

    Report Number
    1627487-2014-25405
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P0100302
    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 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

    DEVICE 3 OF 3. REFERENCE MFR REPORT#: 1627487-2014-25403 AND 25404. IT WAS REPORTED THE PATIENT IS EXPERIENCING SWELLING AND BLEEDING AT THE LEAD INCISION SITE. CULTURES WERE TAKEN AND REVEALED A (B)(6) INFECTION. AS A RESULT, THE PATIENT WAS GIVEN AN ANTIBIOTIC (LEVAQUIN). FOLLOW-UP REVEALED THE PATIENT'S IPG INCISION SITE IS ALSO INFECTED. A CT SCAN WAS TAKEN AND IDENTIFIED NO ANOMALIES. ADDITIONALLY, IT WAS REPORTED THE PATIENT'S DRAINAGE IS MINIMAL AND REDNESS IS WORSE. IN TURN, THE PATIENT WAS GIVEN ANOTHER ANTIBIOTIC. AN SJM REPRESENTATIVE WILL MEET WITH THE PATIENT AT A LATER DATE FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321880 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4452851

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: