BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3911043 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-13058
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 14.5CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT DUE TO EOL, EXTERNALIZED CONDUCTORS WERE NOTED ON THE RV LEAD. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386171 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR