BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3890596 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04419
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 26, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC WITH A DEVICE THAT WAS POST SENSED T WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVE THERAPY. REPROGRAMMING WAS DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31251 RIATA ACTIVE FIXATION DIFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. CRMD 1580/60

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR