BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3953195 · Received July 23, 2014

    Report

    Report Number
    2938836-2014-13569
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR NORMAL ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED. NO ELECTRICAL ANOMALIES WERE DETECTED. PATIENT WAS ASYMPTOMATIC. LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431192 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR