BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 4121728 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07601
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 24, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC.,CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED FOR A NORMAL F/U. THE RIGHT VENTRICULAR LEAD EXHIBITED A HIGH OUT OF RANGE IMPEDANCE VALUE AND NOISE RESULTING IN OVERSENSING. THE LEAD OUTPUT WAS INCREASED AND THE VENTRICULAR SENSITIVITY WAS DECREASED. THE LEAD REMAINED IMPLANTED AND IT WAS DECIDED TO SCHEDULE THE LEAD TO BE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32306 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC.,CARDIAC RHYTHM MANAGEMENT DIVISI 1948/52

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR