BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1254242 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40835
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 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 84 YR Required Intervention THE DEVICE A155/ WAS IMPLANTED| THE DEVICE 4469/412471 WAS IMPLANTED 25-MAR-2004| THE DEVICE T165/143033 WAS IMPLANTED 23-SEP-2008| THE DEVICE A155/103199 WAS IMPLANTED 25-MAR-2004| THE DEVICE 0157/ WAS IMPLANTED| THE DEVICE E110/ WAS IMPLANTED| THE DEVICE E110/ WAS IMPLANTED| THE DEVICE 0157/ WAS IMPLANTED| THE DEVICE A155/ WAS IMPLANTED| THE DEVICE E110/003444 WAS IMPLANTED 23-SEP-2008