BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3872949 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11799
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 5, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC WITH PRESYNCOPAL EPISODES. STORED EGMS SHOWED ONE VF EPISODE RECORDED DUE TO NOISE. PATIENT IS PACEMAKER DEPENDENT. A FOUR SECOND PAUSE DUE TO INHIBITION OF PACING BY NOISE WAS NOTED. NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS. PROGRAMMING CHANGES WERE RECOMMENDED. PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349303 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR