BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3901225 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12616
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 25, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNAL INSULATION ABRASIONS WERE NOTED AT 12.0-13.3CM AND 18.5-19.5CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 9.5-12.8CM FROM THE CONNECTOR PIN. INTERNAL INSULATION ABRASIONS WERE NOTED AT 7.4-8.7CM, 7.5-7.7, 14.4-15.7CM, 15.3-16.0CM, AND 27.0-28.0CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASIONS WERE NOTED AT 12.5-12.7CM AND 17.8-19.4CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED AT 18.3-18.6CM FROM THE CONNECTOR PIN. THE CONDUCTOR WAS FRACTURED AND MELTED AT THIS LOCATION.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380210 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1