BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2984375 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00345
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 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

    NO MEDWATCH FORM WAS RECEIVED. (B)(6) NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL ABRASION WERE FOUND AT 5.5-8.5CM AND 13.2-16.8CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASIONS WERE FOUND AT 14.8-14.9CM AND 15.3-16.6CM FROM DISTAL TIP. EXTERNAL INSULATION ABRASION WAS FOUND AT 23.0-23.5CM FROM DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. 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
    88075 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1