BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC II VR

    MDR report key: 3210713 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03524
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A SET SCREW ANOMALY WAS NOT CONFIRMED SINCE THE SET SCREWS WERE NOT RETURNED. IT IS BELIEVED THAT THE ISSUE MAY HAVE BEEN CAUSED BY SILICONE, SEPTUM MATERIAL IN THE HEX CAVITIES OF THE SET SCREWS. THIS WOULD HAVE PREVENTED FULL INSERTION OF THE TORQUE DRIVER IN THE HELIX CAVITIES AND CAUSED DIFFICULTY TIGHTENING AND LOOSENING THE SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EXPLANT PROCEDURE DUE TO ERI, THE PHYSICIAN WAS UNABLE TO REMOVE THE PACE/SENSE LEAD FROM THE HEADER. THE SEALING AND SCREWS WERE REMOVED TO ALLOW FLUID INTO THE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310494 EPIC II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)