BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISENSE

    MDR report key: 4121706 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07620
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 19, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THE DEVICE WAS PREVIOUSLY PROGRAMMED TO VVI. THE ATRIAL LEAD THEN EXHIBITED INTERMITTENT UNDERSENSING, RESULTING IN INCORRECT DEVICE DISCRIMINATION AND THE DELIVERY OF INAPPROPRIATE HIGH VOLTAGE THERAPY. THE DEVICE WAS REPROGRAMMED AND WAS LEFT IN VVI MODE. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32767 OPTISENSE DTB ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 1699TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR