BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3880478 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03478
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 1, 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
    IL, US
    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. A SET SCREW ISSUE WAS CONFIRMED IN THE LABORATORY. MOST OF THE HEADER WAS MISSING. THE VTIP AND VRING SET SCREWS WERE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UPGRADE THE RV LEAD WAS STUCK IN THE HEADER. A SUSPECTED MEDICAL ADHESIVE HEADER SETSCREW ANOMALY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31215 ATLAS II PLUS DR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D V-268

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR