BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3220030 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04641
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 26, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 UNDERWENT SUCCESSFUL IMPLANTATION OF THE DEVICE. POST-IMPLANT CHEST X-RAY REVEALED A PNEUMOTHORAX. THE PATIENT WAS ASYMPTOMATIC AFTER THE PROCEDURE AND WAS PLACED ON A NON-REBREATHER OXYGEN MASK FOR TREATMENT. THE PATIENT CONDITION IS STABLE AND RELEASED HOME. AT FOLLOW-UP VISIT, A CHEST X-RAY SHOWED A DECREASE IN SIZE OF PNEUMOTHORAX. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320263 QUADRA ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR