BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 4153621 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16414
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6). COMPETITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A DEVICE UPGRADE PROCEDURE, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. ALL ELECTRICAL MEASUREMENTS WERE WITHIN NORMAL RANGE. THE PHYSICIAN ELECTED TO PERFORM A LEAD REVISION DURING THE UPGRADE PROCEDURE. SHORTLY AFTER THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND INTUBATED, HE EXPIRED. THE POCKET WAS NOT YET OPENED. IT WAS NOTED THAT A LOT OF ARTIFACTS WERE SEEN IN THE CARDIAC SIGNAL AND THE PATIENTS BLOOD PRESSURE WAS LOW. COMPRESSIONS WERE STARTED, AND WHEN THE SIGNAL APPEARED TO INDICATE THE PATIENT WAS IN VENTRICULAR FIBRILLATION, EXTERNAL DEFIBRILLATION WAS APPLIED. IT WAS REPORTED THAT THE PATIENT APPEARED TO HAVE A STABLE HEART RHYTHM AT VARYING TIMES, BUT WAS ULTIMATELY NOT ABLE TO MAINTAIN ADEQUATE CARDIAC FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632021 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death