BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1043094 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33539
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other THE DEVICE 6482 014626 WAS USED DURING THE EVENT.| THE DEVICE 4086/222552 WAS IMPLANTED 19-DEC-2005| THE DEVICE 4543/114299 WAS IMPLANTED 19-DEC-2005| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE H210/201118 WAS IMPLANTED 19-DEC-2005