BEUDAMED
    FDA Adverse Event Summary report: N

    UNIFY CRT-D

    MDR report key: 4053553 · Received January 15, 2014

    Report

    Report Number
    2938836-2014-06459
    Date Received
    January 15, 2014
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Report Source
    Manufacturer report
    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 THE DEVICE ENTERED BVVI MODE. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41073 UNIFY CRT-D NIK ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD3231-40

    Patients

    Seq Age Sex Outcome Treatment
    1