BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3123460 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-04610
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    July 24, 2012
    Report Date
    April 26, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 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 OF 2. REF MFR REPORT: 1627487-2013-04611. THE PT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT HAD PASSED A KIDNEY STONE WHICH LED TO AN INFECTION IN HIS BLOOD STREAM. IT WAS REPORTED A PHYSICIAN HAD REMOVED THE SCS SYSTEM DUE TO THE BLOOD INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219125 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3729020

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention