BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2921946 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-05046
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 10, 2012
    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 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

    REFERENCE MFR. REPORT #: 1627487-2013-05044 AND 1627487-2013-05045. IT WAS REPORTED THE PATIENT WAS EXPERIENCING ABDOMINAL STIMULATION. ON (B)(6) 2012, THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO DRAINAGE AT THE IPG SITE. CULTURES WERE TAKEN AND CAME BACK NEGATIVE. ON (B)(6) /2012, THE PATIENT UNDERWENT SURGICAL INTERVENTION. DURING THE PROCEDURE, AN INFECTION WAS FOUND AT THE IPG SITE. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5399 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3728222

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R SCS ANCHORS: MODEL 1192 (2)| EXPLANT:| IMPLANT: