BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3854737 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11506
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS NOTED AT 13.6-14.7CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART, AND AT 13.4-13.9CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. INTERNAL INSULATION ABRASION WAS NOTED AT 14.9-15.4CM AND 15.1-16.9CM FROM THE DISTAL TIP. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 8.4-11.3CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 8.4-11.1CM FROM THE DISTAL TIP. THE ETFE COATING WAS ABRADED AT THIS LOCATION. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 17.0-17.3CM FROM THE DISTAL TIP. THE RV CONDUCTOR SHOWED EVIDENCE OF MELTING AT THIS LOCATION, CONSISTENT WITH THE REPORTED FIELD EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT DUE TO NORMAL ERI, EXTERNALIZED CONDUCTORS WERE SEEN. THE PATIENT WAS ASYMPTOMATIC. THERE WERE ELECTRICAL ANOMALIES AND COMPLICATIONS DURING DFT TESTING. PATIENT RESCUED AT 40J. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331306 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR