BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE EPICARDIAL PATCH LEAD

    MDR report key: 626883 · Received August 10, 2005

    Report

    Report Number
    2124215-2005-10443
    Event Type
    Malfunction
    Date Received
    August 10, 2005
    Date of Event
    June 1, 2005
    Report Date
    June 1, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THESE EPICARDIAL PACING LEADS WERE SURGICALLY ABANDONED WHEN THEY EXHIBITED ELEVATED PACING THRESHOLD MEASEUREMENTS. THE EPICARDIAL PATCH SHOCK LEADS WERE ALSO SURGICALLY ABANDONED WHEN AN OPEN LEAD IMPEDANCE MEASUREMENT WAS DISPLAYED. THE ACCOMPANYING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED WHEN IT DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI). THERE IS NO ALLEGATION AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE EPICARDIAL PATCH LEAD IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0041 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other