BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3801328 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10922
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 17, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN-CLINIC AFTER RECEIVING APPROPRIATE ATP. PATIENT WAS RUNNING FOR THE BUS AT THE TIME OF THE EPISODE. REVIEW OF SEGM SHOWED NOISE. DIAGNOSTIC IMAGINING AND REPLICATING THE NOISE WITH ISOMETRICS AND POCKET MANIPULATION WERE SUGGESTED. IT WAS DETERMINED THAT DUE TO THE AMPLITUDE OF THE NOISE, REPROGRAMMING THE DEVICE WOULD NOT RESOLVE THE ISSUE. THE PATIENT WILL BE MONITORED CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278367 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR