BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 3220382 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04695
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    NA
    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 FIELD EVENT OF A SET SCREW ANOMALY WAS CONFIRMED IN THE LABORATORY. THE CAUSE OF THE ANOMALY WAS DUE TO SILICONE, SEPTUM MATERIAL THAT IS BELIEVED TO HAVE BEEN PRESENT INSIDE OF THE ARING AND ATIP SET SCREW HEX CAVITIES. THE MATERIAL PRESENT IN THE HEX CAVITIES PREVENTED THE TORQUE DRIVER FROM FULLY ENGAGING AND DISENGAGING THE SET SCREWS, LEADING TO THE LEAD REMOVAL DIFFICULTIES REPORTED BY THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT, THE PHYSICIAN HAD DIFFICULTY UNSCREWING THE ATRIAL LEAD FROM THE DEVICE. AFTER MULTIPLE ATTEMPTS THE WHOLE SET SCREW WAS REMOVED. IT WAS NOTED THAT THE SET SCREW HEX CAVITY WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319849 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-341 NA

    Patients

    Seq Age Sex Outcome Treatment
    1