BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3890566 · Received June 3, 2014

    Report

    Report Number
    1627487-2014-08003
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 12, 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

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED DUE TO A FEVER ON (B)(6) 2014. IT WAS LATER DETERMINED THE PATIENT HAD AN INFECTION AT HER SCS IPG SITE. PATIENT WAS DISCHARGED AND SENT HOME WITH A PICC LINE FOR HOME IV ANTIBIOTIC THERAPY. SJM REPRESENTATIVE STATED THAT THE PATIENT'S ANTIBIOTIC THERAPY WILL LAST UNTIL (B)(6). NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324857 EON MINI SCS IPG GZB ST. JUDE MEDICAL, NEUROMODULATION 3788 4486896

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization SCS LEAD, MODEL 3189 (2)| IMPLANT DATE| SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE