BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3801353 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10981
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 18, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 7.5-9.5CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION. INTERNAL INSULATION ABRASIONS WERE NOTED AT 8.3-9.0CM AND 12.5-14.0CM FROM THE DISTAL TIP. THE RV CONDUCTOR ETFE COATING WAS ABRADED AT THESE LOCATIONS. INTERNAL INSULATION ABRASION WAS NOTED AT 13.0-14.0CM FROM THE DISTAL TIP. THE SENSING CONDUCTOR ETFE COATING WAS ABRADED AT THIS LOCATION. INNER COIL LUMEN ABRADED AT 13.1CM AND 27.5CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 27.5-28.2CM FROM THE DISTAL TIP. THE RV CONDUCTOR ETFE COATING WAS ABRADED AND THE INNER COIL WAS EXPOSED AT THIS LOCATION. THESE ETFE ABRASION AND EXPOSED INNER COIL LOCATIONS ARE CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE AND OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED LEAD NOISE DUE TO OVERSENSED NOISE WAS OBSERVED ON A REMOTE TRANSMISSION. THE LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278872 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention