BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 675728 · Received February 9, 2006

    Report

    Report Number
    2124215-2006-12901
    Event Type
    Malfunction
    Date Received
    February 9, 2006
    Date of Event
    October 20, 2005
    Report Date
    October 20, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CHF DEVICE AND LEAD SYSTEM EXPIRED ON AUGUST 19, 2005. THERE WERE NO REPORTED ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE OR LEAD SYSTEM. UPON ARRIVAL AT GUIDANT, PRELIMINARY ANALYSIS ON THE DEVICE IDENTIFIED ARC MARKS ON THE TITANIUM CASING.

    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 72 YR Other