BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192076 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-04789
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    January 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A VISUAL INSPECTION OF THE IPG'S HEADER ASSEMBLY AS RECEIVED PRIOR TO DECONTAMINATION CONFIRMED ONE SETSCREW WAS INVERTED WITH THE SETSCREW HEX SLOT FACING DOWN. THE INVERTED SETSCREW HAD FULLY THREADED AND WAS IN THE FULLY TIGHTENED DOWN POSITION. MECHANICAL ANALYSIS OF THE IPG SETSCREWS FOUND THROUGH VIBRATION TESTING, THE SETSCREWS COULD EXIT THE TERMINAL BLOCK AND INVERT. FURTHER VIBRATION TESTING FOUND ONCE THE SETSCREW INVERTED, IT WAS POSSIBLE TO RETHREAD AND TIGHTEN IN AN UPSIDE DOWN OR INVERTED ORIENTATION. IF THIS OCCURRED, IT WOULD INHIBIT THE HEX WRENCH TO PROPERLY ENGAGE THE SETSCREW SLOT AND MAKE TIGHTENING THE SETSCREW DIFFICULT, WHICH WOULD RESULT IN THE INABILITY TO SECURE THE LEAD IN THE HEADER ASSEMBLY. FURTHER INVESTIGATION OF THE SETSCREW FOUND THE CAVITY FORMED FROM THE SEPTUM INTERFACE WITH THE CONNECTOR BLOCK IS LARGE ENOUGH TO ALLOW THE SET SCREW TO FULLY INVERT AND RESET ITSELF INTO THE CONNECTOR BLOCK UPSIDE DOWN. IT WAS OBSERVED THAT ALL SUBSEQUENT VIBRATIONS ALSO CAN POTENTIALLY CAUSE THE SET SCREW TO MOVE UP AND/OR DOWN WITHIN THE CONNECTOR BLOCK. THE PFMECA RECOGNIZES THE DETECTION LEVEL IS 4 AND YET THE OCCURRENCE RATE IS 1 THUS THE RESULTANT ALARP RISK LEVEL IS ACCEPTABLE AND THUS NO FURTHER ACTION IS REQUIRED. THE NEWLY VALIDATED AND RELEASED HEADER AND ROUND SEPTUM DESIGN 45-0250-XX AND 65-6788-XX WILL REPLACE THIS SEPTUM AND THUS ELIMINATES THE OPPORTUNITY FOR THE SET SCREW TO INVERT. 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

    IT WAS REPORTED THE PATIENT WAS UNDERGOING A PROCEDURE TO REPLACE THE IPG (REFERENCE MFR REPORT: 1627487-2013-02256). DURING THE PROCEDURE THE PHYSICIAN WAS UNABLE TO INSERT THE TORQUE WRENCH INTO THE LOWER SET SCREW OF THE NEW/REPLACEMENT IPG. THE PHYSICIAN NOTED A FUNNEL-SHAPED INDENTATION IN THE HEADER OF NEW IPG AFTER THE PROCEDURE. A DIFFERENT IPG WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THE PROCEDURE WAS EXTENDED 20 MINUTES DUE TO THE SET SCREW ISSUE. THE IPG WAS RETURNED AND TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281066 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3901022

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR