BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4032458 · Received August 25, 2014

    Report

    Report Number
    2938836-2014-14785
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    June 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
    CA, US
    Reporter Occupation
    NURSE

    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 LOW OUT OF RANGE PACING LEAD IMPEDANCE WAS OBSERVED. REPROGRAMMING OPTIONS AND LEAD TESTING WITH ISOMETRICS AND POCKET MANIPULATION WERE SUGGESTED. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513624 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1590/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR