BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D QUAD RF HV

    MDR report key: 6236850 · Received January 10, 2017

    Report

    Report Number
    2938836-2017-02227
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP IN CLINIC, IMPROPER DEVICE OUTPUT WAS OBSERVED. AN "HYS" AND "STIM" MARKER WERE PRESENT ON THE REAL-TIME EGM, EVEN THOUGH HYSTERESIS WAS PROGRAMMED OFF, AND THE PATIENT WAS PACED AT THE BASE RATE. TELEMETRY INTERFERENCE WAS SUSPECTED AS THE CAUSE OF THE MARKER ANOMALY. IT WAS CONFIRMED THAT MULTIPLE EMI SOURCES WERE PRESENT DURING THE DEVICE CHECK. THE PATIENT'S DEVICE WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19659 QUADRA ASSURA CRT-D QUAD RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3365-40Q A000013743

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR