BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D QUAD RF HV

    MDR report key: 6386170 · Received March 7, 2017

    Report

    Report Number
    2938836-2017-17566
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 25, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED LEAD NOISE EPISODES WERE OBSERVED. THE PATIENT WAS ASYMPTOMATIC. REVIEW WAS HAMPERED BY THE LACK OF V-SENSE AMP CHANNEL ON PROGRAMMING FOR THE EVENTS; HOWEVER, WIDENED QRS ON DISCRIMINATION CHANNEL WAS SUGGESTIVE OF POSSIBLE LOSS OF RV CAPTURE. IT WAS EXPLAINED THAT ITS CAPTURE ASSESSMENT IS PERIODIC IN NATURE. IT WAS RECOMMENDED TO REASSESS CAPTURE AND PROGRAMMING OF V-SENSE AMP LEAD VIEW INTO THE STORED EGMS FOR BETTER ASSESSMENT IN FUTURE. DEVICE WAS REPROGRAMMED. PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167237 QUADRA ASSURA CRT-D QUAD RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3365-40Q A000015610

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR