BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 4031696 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14741
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    June 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 A PATIENT PRESENTED A MERLIN TRANSMISSION OF NONSUSTAINED OVERSENSING. OVERSENSING WAS CAUSED BY INTERMITTENT LOSS OF VENTRICULAR CAPTURE WHICH THEN RESULTED IN AN ESCAPE BEAT BEING CALLED NOISE. REINTERROGATION REVEALED NO ISSUES AND THERE WAS NOT ANY CHANGES NEEDED TO MAKE. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508953 QUADRA ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 1581/65, (B)(4)