BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3781958 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10093
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 26, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN THE OPERATING ROOM FOR DEVICE CHANGE OUT DUE TO NORMAL ERI. EXTERNALIZED CONDUCTORS WERE OBSERVED ON DIAGNOSTIC IMAGING. NO ELECTRICAL ANOMALIES WERE DETECTED. LEAD WAS CAPPED AND REPLACED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258816 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR