BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042287 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34354
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 81 YR Other THE DEVICE 4525/160187 WAS IMPLANTED 17-OCT-2006| THE DEVICE H175/316166 WAS IMPLANTED 17-OCT-2006| THE DEVICE 4457/353440 WAS IMPLANTED 28-FEB-2003| THE DEVICE 4480/322825 WAS IMPLANTED 28-FEB-2003| THE DEVICE 6481 042007 WAS USED DURING THE EVENT.| THE DEVICE LATR WAS USED DURING THE EVENT.