BEUDAMED
    FDA Adverse Event Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4053552 · Received January 15, 2014

    Report

    Report Number
    2938836-2014-06445
    Date Received
    January 15, 2014
    Date of Event
    January 8, 2013
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 POST SYSTEM REVISION, PATIENT DEVELOPED AN ALLERGIC REACTION. IT WAS NOTED PATIENT WAS ALLERGIC TO THE CURED MEDICAL ADHESIVE. RESOLUTION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41810 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7120Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1