BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1043431 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33204
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 0184 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other THE DEVICE H215/708594 WAS IMPLANTED 28-AUG-2007| THE DEVICE 4555/156510 WAS IMPLANTED 28-AUG-2007| THE DEVICE 4047/124374 WAS IMPLANTED 29-NOV-2007| THE DEVICE 6487 507020 WAS USED DURING THE EVENT.| THE DEVICE 6482 021421 WAS USED DURING THE EVENT.| THE DEVICE 6483 507070 WAS USED DURING THE EVENT.| THE DEVICE 4047/124373 WAS IMPLANTED 29-NOV-2007| THE DEVICE 4402/BIU243 WAS IMPLANTED 29-NOV-2007| THE DEVICE 4518/328413 WAS IMPLANTED 28-AUG-2007| THE DEVICE 4469/485660 WAS IMPLANTED 28-AUG-2007| THE DEVICE 4525/161809 WAS IMPLANTED 23-OCT-2007| THE DEVICE LATR WAS USED DURING THE EVENT.