BEUDAMED
    FDA Adverse Event Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4053555 · Received January 15, 2014

    Report

    Report Number
    2938836-2014-06488
    Date Received
    January 15, 2014
    Date of Event
    January 25, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD WAS EXPLANTED DUE TO TRICUSPID VALVE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41811 DURATA STS OPTIM ACTIVE FIXATION LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7120/65

    Patients

    Seq Age Sex Outcome Treatment
    1