BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3090103 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01287
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 1, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    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 THE REPORTED DIFFICULTY OF REMOVING THE LEAD WAS CONFIRMED IN THE LABORATORY. THE DIFFICULTY REMOVING THE LEAD WAS FOUND TO BE CAUSED BY SILICONE, SEPTUM MATERIAL FOUND INSIDE THE RV SET SCREW HEX CAVITY. THE MATERIAL PREVENTED FULL INSERTION OF THE TORQUE DRIVER IN THE HEX CAVITIES AND RESULTED IN DIFFICULTY WITH TIGHTENING AND LOOSENING OF THE SET SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT, IT WAS DIFFICULT TO REMOVE THE LEAD FROM THE DEVICE. AFTER SEVERAL ATTEMPTS THE LEAD WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191148 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1