BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3854579 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11542
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 1, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE-OUT FOR NORMAL ERI, THE DEVICE COULD NOT BE INTERROGATED IN ORDER TO TURN OFF THERAPY. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332334 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR