BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950183 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-05467
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEURMODULATION
    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 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 HAD DRAINAGE LOCATED AT THE IPG SITE AS WELL AS AN ODOR. IN TURN, THE WOUND WAS DRAINED AND CULTURES WERE TAKEN. THE PATIENT WAS ALSO PRESCRIBED ORAL ANTIBIOTICS AS A PRECAUTION. FOLLOW-UP REVEALED THE PATIENT HAD A (B)(6) INFECTION. THE DOCTOR BEGAN GIVING THE PATIENT BACTRIM AFTER THE INFECTION WAS CONFIRMED. THE PATIENT WILL BE MONITORED BY HER DOCTOR IN THE MEANTIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376700 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEURMODULATION 3788 4444728

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS EXTENSION: MODEL 3833| IMPLANT DATE:| SCS ANCHOR: MODEL 1194| IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE: