BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 3791023 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10413
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 INABILITY TO REMOVE THE ATRIAL LEAD FROM THE DEVICE WAS CONFIRMED IN THE LABORATORY. UPON RECEIPT, A PARTIAL LEAD WAS CONNECTED TO THE HEADERS ATRIAL PORT. VISUAL INSPECTION IDENTIFIED SILICONE, SEPTUM MATERIAL IN THE ARING SET SCREW HEX CAVITY. THIS MATERIAL PREVENTED FULL INSERTION OF THE TORQUE DRIVER INTO THE HEX CAVITY AND RESULTED IN DIFFICULTY LOOSENING THE SET SCREW, WHICH WAS THE CAUSE OF THE ATRIAL LEAD REMOVAL DIFFICULTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE-OUT FOR NORMAL ERI, THE ATRIAL LEAD COULD NOT BE REMOVED FROM THE DEVICE. THE ATRIAL LEAD WAS CAPPED AND REPLACED DURING THE PROCEDURE. PATIENT CONDITION WAS ALL RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268385 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD V-341 NA

    Patients

    Seq Age Sex Outcome Treatment
    1