BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 4092190 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04998
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 26, 2012
    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
    CA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A SETSCREW ISSUE DURING DEVICE EXPLANT FOR NORMAL ERI. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22813 ATLAS PLUS DR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D V-243

    Patients

    Seq Age Sex Outcome Treatment
    1