BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 4061838 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15502
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 19, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A CONNECTOR ANOMALY COULD NOT BE CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE LEAD PIN IN THE DEVICE HEADER WAS NOT RETURNED. THE DEVICE WAS TESTED ON THE BENCH AND TEST LEADS WERE INSERTED AND ALL SET SCREWS WERE PROPERLY TIGHTENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISCHARGE CHECK, LOSS OF RV CAPTURE WAS OBSERVED. THE LEAD WAS REPOSITIONED. AFTER RE-INSERTING THE LEAD INTO THE DEVICE HEADER, A TUG TEST WAS PERFORMED AND LEAD PULLED OUT, AND THE LEAD PIN BROKE OFF AND WAS STUCK IN THE DEVICE HEADER. A NEW LEAD AND ICD WERE IMPLANTED. THE PATIENT WAS DOING WELL AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539943 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 57 YR 7121Q/65 (B)(4)