BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 659526 · Received November 14, 2005

    Report

    Report Number
    2124215-2005-10966
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Date of Event
    August 2, 2005
    Report Date
    August 2, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    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 FOLLOWING THE PATIENT'S AORTIC VALVE SURGERY, THE SHOCKING IMPEDANCE HAS DECREASED SIGNIFICANTLY AND THERE IS NO P-WAVE SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other