BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3210491 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03274
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 24, 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. RELIABILITY (B)(6) - NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 10.2-11.4CM AND 34.1-34.2CM FORM THE LEAD TIP. INTERNAL INSULATION ABRASION WAS NOTED AT 21.1-21.2CM AND 35.5-35.8CM FROM THE LEAD TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNALIZED CONDUCTORS DUE TO EXTERNAL INSULATION ABRASION WERE NOTED AT 11.4-13.7CM FROM THE LEAD TIP. THE ETFE COATING WAS ABRADED AT 13.5CM FROM LEAD TIP.

    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
    309855 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1