BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3210362 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03242
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 11, 2013
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 6.4-7.6CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO A FEATURE OF THE HEART. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSSULATION ABRASION WAS FOUND AT 13.2-15.3CM AND 13.3-15.3CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION WAS FOUND AT 35.1-36.2CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT ALL ABRASION 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
    310478 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1