BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3801345 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10998
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 18.5CM 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 DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR NORMAL ERI, FAR P-WAVE OVERSENSING AND DOUBLE COUNTING OF QRS WAVES WERE OBSERVED. DURING DFT TESTING, LOW, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE AND AN ALERT FOR A POSSIBLE HIGH VOLTAGE LEAD ISSUE WERE NOTED. THE LEAD WAS CUT, CAPPED, AND A PORTION RETURNED. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279258 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1590/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention CD1257-40, 7011335