BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONI MINI

    MDR report key: 4202431 · Received October 21, 2014

    Report

    Report Number
    1627487-2014-20353
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 4, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION SYSTEMS
    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 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 1 OR 2. REF MFR REPORT # 1627487-2014-20354. IT WAS REPORTED THE PT EXPERIENCED ITCHING AND REDNESS AROUND THE IPG AND THE LEAD SITE. THE PHYSICIAN SUSPECTED AN INFECTION AND TREATED THE PT WITH ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669548 EONI MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION SYSTEMS 3788 4579945

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other