BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3881006 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02299
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 29, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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 REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IN CLINIC FOLLOW UP THE DEVICE WAS POST PACED T WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVE THERAPY. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25212 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFRIBILLATOR, NIK NIK ST. JUDE MEDICAL, INC. CRMD 3207-36

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR