BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 4811030 · Received June 2, 2015

    Report

    Report Number
    3010215456-2015-00379
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 18, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF SET SCREW ANOMALY WAS CONFIRMED IN THE LABORATORY. THE VTIP SEPTUM WAS MISSING AND THE VTIP SET SCREW WAS NOT RETURNED. THE VRING SEPTUM WAS DAMAGED AND THE VRING SET SCREW WAS NOT RETURNED. NONE OF THE SET SCREWS WERE FOUND TO BE DAMAGED AND ALL BUT THE VTIP AND VRING SET SCREWS (NOT RETURNED) HAD SILICONE IN THEIR HEX CAVITIES. THIS MATERIAL MAY HAVE 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 ELECTIVE DEVICE REPLACEMENT, A SET SCREW COULD NOT BE UNTIGHTEN. THE LEAD WAS CUT OFF IN ORDER TO RELEASE THE DEVICE. NO ADVERSE CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355732 ATLAS PLUS DR IMPANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. (CRM-KISTA) V-243 2911547

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention