BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2926073 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-03131
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 SPECS 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

    DEVICE 1 OF 3. REF MFR REPORTS: 1627487-2013-03132 & 1627487-2013-03133. THE PT RECEIVED 2 SCS EXTENSIONS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS ADMITTED TO THE HOSP DUE TO AN INFECTION. SUBSEQUENTLY, THE PT'S SCS SYSTEM WAS EXPLANTED. F/U IDENTIFIED THE PT HAS AN MRSA INFECTION AT THE SCS IPG POCKET AND SCS LEAD SITES. ON (B)(6) 2013 F/U IDENTIFIED THE PT IS UNDERGOING REHABILITATION THERAPY AND IS RECEIVING INTRAVENOUS ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26249 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3869736

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R SCS ANCHOR: MODEL 1194(2)| IMPLANT DATE: