BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3090036 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01092
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    December 26, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A PARTIAL LEAD MEASURING 50.8 CM OF THE DISTAL LEAD SEGMENT WAS RETURNED FOR ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 7.0-9.4CM AND 17.4-19.8CM FROM THE DISTAL TIP. THE SILICONE INSULATION WAS ABRADED AND THE SENSING CONDUCTORS WERE VISIBLE. INTERNAL INSULATION ABRASION WAS FOUND AT 11.9-12.1CM AND 36.1-36.6CM FROM THE DISTAL TIP. EXTERNAL INSULATION ABRASION WAS FOUND AT 43.1CM-43.6CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT ALL ABRASION LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RECENTLY IMPLANTED SYSTEM WAS EXPLANTED DUE TO INFECTION. DURING THIS PROCEDURE, EXTERNALIZED CONDUCTORS WERE NOTED ON THE PREVIOUSLY CAPPED LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191467 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1591/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR