BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3810533 · Received May 6, 2014

    Report

    Report Number
    1627487-2014-12330
    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 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 THE STERILIZATION RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IPG INCISION HAS BEEN OOZING SINCE THE IMPLANT DATE. THE CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS. THE PATIENT IS RECEIVING INTRAVENOUS ANTIBIOTICS. THE PHYSICIAN EXPLANTED THE IPG, BUT THE LEAD WAS LEFT IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271541 EON SCS IPG GZB ST. JUDE MEDICAL NEUROMODULATION 3716 4110795

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE: