BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 3210585 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03540
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 11, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR ROUTINE FOLLOW-UP, ATRIAL UNDERSENSING WAS NOTED. IT WAS ALSO NOTED THAT THE DEVICE HAD REACHED ERI NORMALLY. THE DEVICE WAS REPLACED DUE TO THE NORMAL ERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311591 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR