BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC DR

    MDR report key: 3447527 · Received November 4, 2013

    Report

    Report Number
    2938836-2013-07742
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Date of Event
    July 25, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF A SET SCREW ANOMALY WAS CONFIRMED IN THE LABORATORY. THE CAUSE OF THE ANOMALY WAS DUE TO SILICONE, SEPTUM MATERIAL FOUND INSIDE OF THE RV DF-1 AND V IS-1 BI SET SCREW HEX CAVITIES. THE SILICONE, SEPTUM PREVENTED FULL INSERTION OF THE TORQUE DRIVER INTO THE HEX CAVITY. IT WAS ALSO NOTED AT THE RV DF-1 AND V IS-1 BI SEPTA WERE FOUND TO BE DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EXPLANT PROCEDURE, SET SCREW ON DEVICE HEADER APPEARED TO BE STRIPPED. THE PHYSICIAN COULD NOT UNSCREW AND REMOVE THE PACE/SENSE PORTION OF THE RV LEAD. THE ICD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565954 EPIC DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-233 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR