BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1041706 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34936
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 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 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other THE DEVICE H210/216344 WAS IMPLANTED 31-JAN-2008| THE DEVICE 4542/118040 WAS IMPLANTED 31-JAN-2008| THE DEVICE 4308/100374 WAS IMPLANTED 11-APR-2005| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6482 028618 WAS USED DURING THE EVENT.