BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II VR

    MDR report key: 3880441 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03501
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 21, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP THE PHYSICIAN FOUND AN EPISODE OF T-WAVE OVERSENSING. THIS WAS RESOLVED BY REPROGRAMMING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24771 ATLAS II VR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D V-168

    Patients

    Seq Age Sex Outcome Treatment
    1