BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1042810 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33841
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 0147 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other THE DEVICE 4087/201360 WAS IMPLANTED 02-MAR-2004| THE DEVICE 6481 036109 WAS USED DURING THE EVENT.| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE T125/102169 WAS IMPLANTED 02-MAR-2004