BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2890056 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10759
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 31, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Adverse Event
    Yes
    Product Problem
    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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 10.0-12.5CM FROM THE ELECTRODE TIP. SILICONE INSULATION WAS ABRADED AND RV AND SENSING CONDUCTORS WERE VISIBLE. EXTERNAL INSULATION ABRASION WAS FOUND AT 15.5-16.2CM FROM THE ELECTRODE TIP. ETFE COATING WAS INTACT AT THIS LOCATION. INTERNAL INSULATION ABRASION WAS FOUND AT 8.4-9.2CM FROM THE ELECTRODE TIP. THE ETFE COATING WAS INTACT BUT THE INNER COIL WAS EXPOSED. THIS DAMAGE IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED VIA X-RAY. NOISE WAS NOTED. LEAD WAS EXPLANTED.

    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 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1