BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1043215 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33436
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 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 70 YR Other THE DEVICE 4513/405618 WAS IMPLANTED 10-NOV-2005| THE DEVICE H215/700302 WAS IMPLANTED 10-NOV-2005| THE DEVICE 6487 505100 WAS USED DURING THE EVENT.| THE DEVICE 6483 505120 WAS USED DURING THE EVENT.| THE DEVICE 6482 000522 WAS USED DURING THE EVENT.| THE DEVICE 4470/463485 WAS IMPLANTED 10-NOV-2005