BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3854714 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11622
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS PRESENTED IN THE OPERATING ROOM FOR CHANGE OUT DUE TO NORMAL ERI. PRE-OPERATIVE FLUOROSCOPY WAS DONE AND REVEALED THE LEAD HAVING EXTERNALIZED CONDUCTORS. LEAD REMAINS IMPLANTED. PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330976 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR