BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3220046 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04643
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    April 1, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED CAPACITOR MAINTENANCE ANOMALY WAS NOT CONFIRMED AS IT COULD NOT BE REPRODUCED DURING TESTING ON THE BENCH WHILE PERFORMING MANUAL CAPACITOR MAINTENANCE CHARGES. THE DEVICE TESTED NORMALLY. THE CAUSE OF THE EVENT OBSERVED IN THE FIELD COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT PROCEDURE WHILE ICD WAS IN THE BOX, AN ERROR MESSAGE WAS OBSERVED DURING CAPACITOR MAINTENANCE CHECK, STATING UNABLE TO FIND THE DEVICE VIA PROGRAMMER. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319819 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