BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2902508 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00296
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    October 5, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    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 35.5-37.8CM FROM THE ELECTRODE TIP. THE SILICONE INSULATION WAS ABRADED AND THE SENSING, RV, AND SVC CONDUCTORS WERE VISIBLE AT THE SAME LOCATION. THE INNER CONDUCTOR WAS EXPOSED. OTHER INTERNAL INSULATION ABRASIONS WERE FOUND AT 8.1-8.5CM AND 14.8-16.1CM FROM THE ELECTRODE TIP. THE ETFE COATING WAS INTACT AT ALL ABRASION LOCATIONS. THE EXPOSED INNER CONDUCTOR COULD HAVE CAUSED THE REPORTED NOISE. WITHOUT RETURN OF AN ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING A PATIENT NOTIFIER. AN OUT OF RANGE IMPEDANCE MEASUREMENT WAS OBSERVED. UPON INTERROGATION, SEVEN EPISODES OF VF DUE TO NOISE WERE REVEALED. PATIENT RECEIVED NO INAPPROPRIATE SHOCKS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9788 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1