BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 4191794 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05433
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    August 23, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DTB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION DESCRIPTION: FINAL ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEFT VENTRICULAR LEAD DISSECTED THE VEIN WHILE APPLYING CONTRAST MEDIUM THROUGH THE BALLOON CATHETER. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28851 QUARTET DTB ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 1458Q/75

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention