BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4760459 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04741
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    March 25, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RELATED COMPLAINT RECEIVED WITH RETURN OF DEVICE. CONCLUSION: FAILURE (EVENT) OBSERVED DURING ANALYSIS. A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 7.-7.8CM, 13.9-14.1CM, 16.1-16.2CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INITIAL REPORTER: RELIABILITY LABORATORY TECHNICIAN. ST. JUDE MEDICAL (B)(4) 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
    305060 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR