BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 783558 · Received November 9, 2006

    Report

    Report Number
    2124215-2006-17419
    Event Type
    Malfunction
    Date Received
    November 9, 2006
    Date of Event
    August 3, 2006
    Report Date
    August 3, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS VENTRICULAR LEAD HED IMPEDANCE MEASUREMENTS INCREASE FROM 600 OHMS TO GREATER THAN 2500 OHMS, IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS. THE PACING IS NOT CONSISTENT. THE PATIENT HAD FALLEN THE WEEK THAT THE LEAD IMPEDANCE MEASUREMENTS WENT UP TO 2500 OHMS. A LEAD REVISION PROCEUDRE WAS THEN PERFORMED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4087 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other