BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3810612 · Received May 6, 2014

    Report

    Report Number
    1627487-2014-12331
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 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

    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 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 4. REFERENCE MFR REPORT #1627487-2014-12332, REFERENCE MFR REPORT #1627487-2014-12333, AND REFERENCE MFR REPORT #1627487-2014-12334. IT WAS REPORTED THE PATIENT REPORTED A FEVER AND FEELING SICK. SHE ALSO REPORTED PAIN AT THE IMPLANT SITE. IT IS UNKNOWN WHICH IMPLANT SITE WAS CAUSING THE PAIN. THE PHYSICIAN PRESCRIBED ANTIBIOTICS. F/U REVEALED THE PATIENT IS FEELING BETTER AND THE PAIN AT THE IMPLANT SITE IS IMPROVING. THE PATIENT WILL CONTINUE HER COURSE OF ANTIBIOTICS AND F/U WITH HER PHYSICIAN. NOTE THE PATIENT HAS 2 ANCHORS FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271390 EON MINI SCS IPG GZB ST. JUDE MEDICAL, NEUROMODULATION 3788 4438940

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other