BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1253732 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40083
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    August 31, 2008
    Report Date
    August 31, 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 0157 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention THE DEVICE 4469/338094 WAS IMPLANTED 27-APR-2004| THE DEVICE T125/105069 WAS IMPLANTED 27-APR-2004