BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D DF4 CONNECTOR

    MDR report key: 4091873 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05176
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 12, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS VIBRATORY ALERT WAS ACTIVATED DUE TO POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. THE OVERSENSING WAS NOTED IN STORED EGM. THE PATIENT DID NOT RECEIVE ANY INAPPROPRIATE THERAPY. THE DEVICE WAS REPROGRAMMED SUCCESSFULLY. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33883 QUADRA ASSURA CRT-D DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC., CRMD CD3267-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR