BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3880609 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03407
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 21, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY THE MFR, 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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT PRESENTED IN THE EMERGENCY ROOM AFTER FEELING LIGHT HEADED. IT WAS OBSERVED THAT THE LEAD EXHIBITED INTERMITTENT UNDERSENSING ON THE VENTRICULAR CHANNEL. THERE WAS VARIATION IN THE R WAVE AMPLITUDE CAUSING SEVERAL EVENTS TO THE UNDERSENSED, THIS CAUSED THE DEVICE TO INAPPROPRIATELY RETURN TO SINUS AND ABORT THE HIGH VOLTAGE THERAPY. REPROGRAMMING WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25060 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD, NVY NVY ST. JUDE MEDICAL INC., CRMD 7020/60

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR