BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4153660 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16453
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED A MERLIN TRANSMISSION IN CLINIC FOR AN ALERT FOR LOWER OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. EXTERNALIZED CONDUCTORS WERE OBSERVED WHEN THE LEAD WAS EXPLANTED. LEAD WILL NOT BE RETURNED. THE PATIENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631847 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention