BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 4091584 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04884
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 31, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION INCLUDED. EXTERNALIZED CONDUCTORS DUE TO EXTERNAL INSULATION ABRASION WAS FOUND 7.5-10.5CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION WITH ANOTHER DEVICE. AN EXTERNAL INSULATION ABRASION WAS OBSERVED AT 14.5-15.0CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION WITH ANOTHER DEVICE. 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
    22546 RIATA ACTIVE FIXATION LEAD DEFIBRILLATION LEAD, NVY NVY ST. JUDE MEDICAL INC., CRMD 1581/65

    Patients

    Seq Age Sex Outcome Treatment
    1