BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE EZ

    MDR report key: 1043467 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33184
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE EZ IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention THE DEVICE 0184/144997 WAS IMPLANTED 05-FEB-2008| THE DEVICE 4086/215949 WAS IMPLANTED 03-JAN-2005| THE DEVICE 4320/016241 WAS IMPLANTED 29-JUL-1992| THE DEVICE 1782/502478 WAS IMPLANTED 04-DEC-1998| THE DEVICE T180/211188 WAS IMPLANTED 05-FEB-2008| THE DEVICE 4320/016242 WAS IMPLANTED 29-JUL-1992| THE DEVICE 0095/202745 WAS IMPLANTED 04-DEC-1998| THE DEVICE 0041/144412 WAS IMPLANTED 29-JUL-1992| THE DEVICE 4135/282663 WAS IMPLANTED 05-FEB-2008| THE DEVICE 0041/144413 WAS IMPLANTED 29-JUL-1992| THE DEVICE H179/504298 WAS IMPLANTED 03-JAN-2005