BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1253842 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40587
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    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 94 YR Other THE DEVICE E110/ WAS IMPLANTED| THE DEVICE E110/003442 WAS IMPLANTED 16-SEP-2008| THE DEVICE E110/002421 WAS IMPLANTED 10-SEP-2008| THE DEVICE A135/105959 WAS IMPLANTED 03-SEP-2003| THE DEVICE T165/144259 WAS IMPLANTED 16-SEP-2008