BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3901260 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12641
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 46.4CM WAS RETURNED FOR ANALYSIS. INTERNAL INSULATION ABRASION WAS NOTED AT 9.8-9.9CM FROM THE DISTAL TIP. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 9.8-12.6CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. RELIABILITY LABORATORY TECHNICIAN ST. JUDE MEDICAL CRMD RELIABILITY LABORATORY ST. JUDE MEDICAL CRMD RELIABILITY LABORATORY

    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
    380259 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1