BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIFY CRT-D

    MDR report key: 3627405 · Received February 13, 2014

    Report

    Report Number
    2938836-2014-04713
    Event Type
    Other
    Date Received
    February 13, 2014
    Date of Event
    August 22, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 PT PRESENTED IN CLINIC DURING A FOLLOW UP AND THE DEVICE WAS POST PACED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96115 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC., CRMD CD3231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female