BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3892800 · Received June 24, 2014

    Report

    Report Number
    2938836-2014-12383
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED IN THREE SEGMENTS FOR ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 9.1-14.4CM FROM THE DISTAL TIP. THE ETFE COATING WAS DAMAGED DURING EXPLANT AT THIS LOCATION. INTERNAL INSULATION ABRASION WAS NOTED AT 13.4-14.2CM, 14.6-14.7CM, AND 32.8-32.9CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASION WAS NOTED AT 51.1-51.3CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE ETFE COATING OF ONE SENSING CONDUCTOR WAS ABRADED AT THIS LOCATION. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 9.0-13.5CM FROM THE DISTAL TIP. THE ETFE COATING OF ONE SENSING CONDUCTOR WAS ABRADED AND THE INNER COIL WAS EXPOSED AT THIS LOCATION. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 25.0-25.3CM FROM THE DISTAL TIP. THE ETFE COATING OF ONE SVC CONDUCTOR WAS ABRADED. THE INNER COIL WAS EXPOSED AT THIS LOCATION. THE ABRASIONS IN WHICH EITHER THE ETFE COATING OF THE SENSING CONDUCTOR WAS ABRADED OR THE INNER COIL WAS EXPOSED WERE CONSISTENT WITH THE FIELD OBSERVATION OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED DUE TO NOISE RESULTING IN TWO ABORTED VF SHOCKS. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369439 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention