BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II VR

    MDR report key: 4030712 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14719
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 22, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOLLOWING DEVICE SOFTWARE RESET. THE PATIENT REPORTS BEING NEAR A PERSONAL GENERATOR CLOSE TO THE TIME OF RESET. PROGRAMMING CHANGES WERE MADE AND THE DEVICE WAS CORRECTED WITH NO FURTHER ISSUES. THE PATIENT WILL BE OBSERVED FOR ERI INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509863 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR