BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3791211 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10404
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 6, 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 THE PATIENT PRESENTED IN THE OPERATING ROOM FOR A DEVICE CHANGE OUT DUE TO NORMAL ERI. DURING DFT TESTING WITH NEW DEVICE, FIRST THERAPY RESULTED IN LOW HIGH VOLTAGE LEAD IMPEDANCE. PHYSICIAN ELECTED TO CAP AND REPLACED THE LEAD. NO ADDITIONAL COMPLICATIONS OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268470 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR