BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2243013 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06215
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    July 25, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    DURING A ROUTINE ERI CHANGE OUT, AFTER THE TERMINAL PINS OF THE RV LEAD WERE PLACED IN THE NEW DEVICE, NO IMPEDANCE MEASUREMENTS WERE OBSERVED ON THE RV TO CAN AND SVC/RV TO CAN VECTORS. THE PHYSICIAN REVERSED THE COIL TERMINAL PINS, AND THE RESULTS WERE THE SAME. A SECOND DEVICE WAS USED. IT WAS DETERMINED THAT THE RV COIL WAS FRACTURED. THE RV COIL WAS CAPPED. THE SVC COIL WAS PLACED INTO THE RV COIL PORT. DFT TESTING WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention