BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 3854619 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11543
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 15, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A ROUTINE CLINICAL FOLLOW-UP, POST PACED T-WAVE OVERSENSING WAS OBSERVED. THE OVERSENSING COULD NOT BE REPRODUCED IN CLINIC. THE PROVOCATIVE AND POCKET MANIPULATION TESTS WERE NORMAL. PHYSICIAN ELECTED TO MAKE NO CHANGES AND THE PATIENT MEDICAL CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332118 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1