BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 4191785 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04675
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    August 16, 2012
    Manufacturer
    ST. JUDE MEDICAL INC. CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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: THE REPORTED SENSING AND HELIX ANOMALIES EXPERIENCED DURING THE LEAD DISLODGEMENT COULD NOT BE REPRODUCED IN THE LAB. THE DEVICE WAS VISUALLY INSPECTED AND A MECHANICAL/ELECTRICAL TEST WAS CONDUCTED. THERE WERE NO ANOMALIES OBSERVED DURING THESE TESTS AND THE LEAD IS FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICLE LEAD WAS DISLODGED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28850 QUARTET PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL INC. CRMD 1458Q/86

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention