BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 4190136 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04189
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    September 12, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 LOSS OF CAPTURE COULD NOT BE CONFIRMED. THE DEVICE WAS TESTED ON THE BENCH AND EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. A VISUAL/MECHANICAL INSPECTION WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE FOR DISLODGMENT, WHICH IN TURN CAUSED A LOSS OF CAPTURE, COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. THE LEAD DISLODGED DUE TO THE SUTURE SLEEVE NOT BEING TIED TIGHTLY. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25061 QUARTET PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1458Q/86

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention