BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3880648 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03386
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 29, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOOD FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WAS SHORT OF BREATH WHEN PRESENTED IN HOSPITAL DUE TO LOSS OF CAPTURE. NOISE WAS SUSPECTED TO BE SEEN ON BOTH EGMS. THE VENTRICULAR OUTPUT WAS INCREASED. LEAD WAS PLANNED TO BE TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25168 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD, NVY LWS ST. JUDE MEDICAL INC., CRMD 7000/60

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR