BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2902613 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00291
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 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 7.8-13.7CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION. INTERNAL INSULATION ABRASION WAS FOUND UNDER THE SVC SHOCK COIL AT 17.8-1 8.2CM FROM THE DISTAL TIP. ONE OF THE RV CONDUCTORS AND THE SVC SHOCK COIL WERE PARTIALLY MELTED IN THIS REGION. THIS DAMAGE IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF LOW LEAD IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING THERAPY. UPON INTERROGATION, LOW HV LEAD IMPEDANCE WAS OBSERVED. DURING DEVICE CHANGE OUT, EXTERNALIZED CONDUCTORS WERE OBSERVED. LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8846 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR (B)(4)