BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3901082 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12685
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 12, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A HEADER ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. VISUAL INSPECTION NOTED FOREIGN MATERIAL ON THE A AND LV SPRINGS. TEST LEADS WERE INSERTED AND SECURED WITH NO ANOMALIES. THE CAUSE OF THE HEADER ANOMALY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE ATRIAL LEAD WAS UNABLE TO BE CONNECTED TO THE DEVICE. SEVERAL ATTEMPTS WERE MADE TO CONNECT THE LEAD TO THE HEADER. THE DEVICE WAS NOT IMPLANTED AND WAS REPLACED. PATIENT IS DOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381298 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 71 YR