BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2984367 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00299
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    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 RELIABILITY LABORATORY TECHNICIAN; (B)(6). NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. AN EXTERNAL INSULATION ABRASION WAS NOTED AT 15.1CM-15.4CM FROM TIP, CONSISTENT WITH FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT THIS LOCATION. INTERNAL ABRASIONS WERE NOTED UNDER THE SVC SHOCK COIL AT 24CM-24.3CM AND 24.2CM-24.5CM FROM THE TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION.

    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
    88028 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1