BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2781477 · Received October 10, 2012

    Report

    Report Number
    2017865-2012-08915
    Event Type
    Death
    Date Received
    October 10, 2012
    Date of Event
    September 27, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, AN INCREASE IN THE LEFT VENTRICULAR PACING THRESHOLD WAS NOTED. THE ATRIAL LEAD AND RV LEADS WERE FUNCTIONING PROPERLY. ALL THE ELECTRICAL MEASUREMENTS WERE STABLE. THE PHYSICIAN DECIDED TO EXTRACT THE LV AND RV LEADS. DURING PROCEDURE THE BLOOD PRESSURE OF THE PATIENT SUDDENLY DECREASED AND THE HEART DIDN'T CONTRACT DUE TO A PERICARDIAL TAMPONADE. AFTER MASSIVE BLOOD DRAIN, DAMAGE TO THE VENOUS WALL STARTING FROM SUPERIOR VENA CAVA INTO THE RIGHT ATRIUM WAS NOTED, PROBABLY CAUSED BY THE LASER AND THE ADHERENCES OF THE SVC COIL ON THE VENOUS WALL. THE PHYSICIAN TRIED TO REPAIR THE VENOUS WALL KEEPING THE PATIENT IN EXTRA CORPOREAL CIRCULATION. AFTER 4 HOURS OF INTERVENTION THE PATIENT EXPIRED. PHYSICIAN DOES NOT ALLEGE RV LEAD FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death (B)(4)