BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4202055 · Received October 21, 2014

    Report

    Report Number
    1627487-2014-24302
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT IS EXPERIENCING AN INFECTION AT THE IPG SITE. A NEEDLE ASPIRATION REVEALED PUS AT THE IPG SITE. CULTURES REVEALED (B)(6). SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SCS SYSTEM WAS EXPLANTED. THE PT IS PUT ON ORAL ANTIBIOTICS AND NO FURTHER SIGNS OF INFECTION ARE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670220 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 4452855

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other SCS LEAD, MODEL: 3186 (2)| IMPLANT DATE: