BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1041815 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34834
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    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 Required Intervention THE DEVICE 4096/124886 WAS IMPLANTED 31-JUL-2006| THE DEVICE 1861/267064 WAS IMPLANTED 31-JUL-2006| THE DEVICE 0185/ WAS IMPLANTED 21-MAR-2008| THE DEVICE 0185/ WAS IMPLANTED| THE DEVICE 0185/189976 WAS IMPLANTED 21-MAR-2008