BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 783559 · Received November 9, 2006

    Report

    Report Number
    2124215-2006-17420
    Event Type
    Malfunction
    Date Received
    November 9, 2006
    Date of Event
    August 3, 2006
    Report Date
    September 15, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    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 RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAS BEEN DEMONSTRATING A GRADUAL INCREASE IN PACING IMPEDANCE SINCE IMPLANT (755 OHMS AT IMPLANT, VALUES NOTED SINCE THEN: 902, 1646 AND 1930 OHMS). IT WAS REPORTED THAT THE PACING THRESHOLDS ARE STABLE AT 1.6V AND THAT THE R WAVE AMPLITUDE HAS ALWAYS BEEN SOMEWHAT LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 0147 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other