BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1041690 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34961
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention THE DEVICE H217/714603 WAS IMPLANTED 08-JAN-2008| THE DEVICE 4136/282522 WAS IMPLANTED 08-JAN-2008| THE DEVICE 4543/134288 WAS IMPLANTED 08-JAN-2008| THE DEVICE 0185/168920 WAS IMPLANTED 03-MAR-2008| THE DEVICE 4135/244496 WAS IMPLANTED 08-JAN-2008| THE DEVICE 4543/132127 WAS IMPLANTED 03-MAR-2008