BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 4160754 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01929
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    July 20, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE REPORTED FIELD EVENT OF NOISE WAS CONFIRMED VIA REVIEW OF STORED ELECTROGRAMS IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND OUR AUTOMATED TESTING EQUIPMENT. THE DEVICE FUNCTIONS ARE NORMAL AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO SEVERAL VF EPISODES CAUSED BY NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26657 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD V-243

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 1582/65 RJ016746