BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3854741 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11571
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 WHEN AN ASYMPTOMATIC PATIENT PRESENTED TO THE OPERATING ROOM FOR A DEVICE CHANGE-OUT, NOISE ON THE RV LEAD CHANNEL WAS OBSERVED VIA STORED EGM. ELECTRICAL MEASUREMENTS WERE STABLE AND WITHIN NORMAL RANGES. THE NOISE COULD NOT BE REPRODUCED. THE LEAD WAS CAPPED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331584 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1571/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR