BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 4153721 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16458
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 7, 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 Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING DEVICE REPLACEMENT, IT WAS OBSERVED THAT THE LEAD COULD NOT BE DISCONNECTED FROM THE DEVICE DUE TO THE SET SCREW NOT UNSCREWING. THE LEAD WAS CUT AND CAPPED AND THE DEVICE WAS EXPLANTED. THE PATIENT CONDITION WAS GOOD AFTER THE EVENT AND THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631679 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD V-341 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1580/65, RE43412