BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042133 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34508
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 13, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE H195/355336 WAS IMPLANTED| THE DEVICE 4096/113519 WAS IMPLANTED| THE DEVICE H195/306091 WAS IMPLANTED| THE DEVICE 4517/414572 WAS IMPLANTED| THE DEVICE 0181/109611 WAS IMPLANTED