BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3910988 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12955
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 7, 2014
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.THE REPORTED FIELD EVENT OF THE INABILITY TO LOOSEN THE SVC SET SCREW WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION IDENTIFIED SILICONE, SEPTUM MATERIAL INSIDE THE SVC SET SCREW HEX CAVITY. THIS MATERIAL PREVENTED FULL INSERTION OF THE TORQUE DRIVER IN THE HEX CAVITY AND RESULTED IN DIFFICULTY LOOSENING THE SET SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE REPLACEMENT DUE TO ERI, THE PHYSICIAN HAD DIFFICULTY UNSCREWING THE LEAD FROM THE HEADER OF THE DEVICE. THE PHYSICIAN WAS SUCCESSFUL AFTER SEVERAL ATTEMPTS. THE DEVICE WAS EXPLANTED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387369 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1