BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4061903 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15523
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    April 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
    PA, 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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR NON-SUSTAINED OVERSENSING EPISODE. EGM STRIPS REVEALED INTERMITTENT CROSSTALK EPISODES. AN ALERT FOR HIGH VOLTAGE LEAD IMPEDANCE OUT OF RANGE WAS OBSERVED. PROGRAMMING CHANGES WERE MADE AND WILL MONITOR THE HV CIRCUIT. PATIENT CONDITION IS GOOD AND IS SCHEDULED FOR ROUTINE FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540993 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1590/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR CD2311-36,7032299