BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 3090145 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01275
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 22, 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 Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A SET SCREW ANOMALY COULD NOT BE CONFIRMED DUE TO THE SET SCREWS NOT BEING RETURNED. THE DEVICE WAS TESTED ON THE BENCH. THE RETURNED SEPTA WERE FOUND TO BE PUNCTURED. NEW SET SCREWS WERE INSERTED IN THE CONNECTOR BLOCKS NORMALLY AND SECURED. IT IS BELIEVED THAT THE CAUSE OF THE ANOMALY WAS DUE TO SILICONE, SEPTUM MATERIAL IN THE SET SCREW HEX CAVITIES. THE SILICONE MATERIAL IN THE SET SCREW HEX CAVITIES CAN PREVENT THE TORQUE DRIVER FROM BEING FULLY INSERTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED FOR NORMAL DEVICE REPLACEMENT DUE TO ERI. DURING THE PROCEDURE THE PHYSICIAN HAD DIFFICULTY LOOSENING THE RV LEAD CONNECTOR SET SCREW. THE PHYSICIAN REMOVED THE SEPTUM IN ORDER TO LOOSEN THE SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191730 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR