BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3925377 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08883
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    December 13, 2012
    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
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 LEFT VENTRICLE LEAD WAS DISLODGED. THE LEFT VENTRICLE LEAD WAS PROGRAMMED OFF UNTIL THE DOCTOR REPOSITIONED THE LEAD. ALL READINGS FROM THE LEAD WERE NOMINAL AFTER BEING REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38244 QUARTET DTB ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 1458Q/75

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention