BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2950156 · Received February 8, 2013

    Report

    Report Number
    2938836-2013-00038
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 3, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    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. FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO EXTERNAL INSULATION ABRASION WERE FOUND AT 9.2-12.5CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. THE SILICONE INSULATION WAS ABRADED AND THE RV CONDUCTOR WAS VISIBLE. ANOTHER EXTERNAL INSULATION ABRASION WAS FOUND AT 12.1-12.4CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    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
    53673 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1