BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 3220034 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04687
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 16, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 PERIODS OF NO VENTRICULAR PACING WERE SEEN ON AN EXTERNAL EKG WHILE THE DEVICE WAS EXPECTED TO BE PACING. THE PATIENT WAS EXPERIENCING ATRIAL FIBRILLATION AT THE TIME. REVIEW OF STORED EGMS REVEALED AN ATRIAL NOISE EPISODE WITHOUT PACING SUPPRESSION. REPROGRAMMING WAS SUGGESTED AND THE DEVICE WAS LATER EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319815 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention