BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4173952 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16707
    Event Type
    Injury
    Date Received
    October 15, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 12.1CM WAS RETURNED FOR ANALYSIS. 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 PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPIES. STORED EGMS REVEALED NOISE EPISODES. INCREASED PACING LEAD IMPEDANCE AND DECREASED SENSING WERE ALSO NOTED. LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655885 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention