BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3791199 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10366
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 21, 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
    OH, 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 WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP, NOISE WAS OBSERVED ON ATRIAL AND RV LEADS. THE PATIENT WORKS WITH ELECTRICAL HAND TOOLS AND ALSO HAD MULTIPLE SHORT DURATION AUTO MODE SWITCH EVENTS CAUSED BY EMI, BUT THEY ARE NOT CONSISTENT WITH TIMES OF THE DAY WHEN PATIENT WOULD BE USING TOOLS. THE NOISE WAS NOT REPRODUCED WITH POCKET MANIPULATION AND X-RAY WAS NORMAL. POSSIBLE LEAD RUB WAS SUSPECTED. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268466 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR (B)(4)