BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3801318 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10902
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 7, 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
    AL, 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 THE PATIENT PRESENTED IN CLINIC WITH NON-SUSTAINED VT EPISODES DUE TO NOISE. ALL ELECTRICAL MEASUREMENTS WERE WITHIN RANGE. NOISE COULD BE REPRODUCED IN-CLINIC. SUSPECTED LOOSE SET SCREW WAS NOTED. THE PATIENT HAS AN ABANDONED PACE/SENSE PORTION OF THE PREVIOUS LEAD IN RIGHT VENTRICLE AND IT WAS CONFIRMED VIA X-RAY THAT IT WAS NOT TOUCHING THE IMPLANTED ACTIVE LEAD. PROGRAMMING CHANGES WERE MADE AND THE SYSTEM WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279188 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR