BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1041711 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34926
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 29, 2008
    Report Date
    March 29, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0138 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other THE DEVICE 1861/246231 WAS IMPLANTED 26-MAR-2003| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6481 310917 WAS USED DURING THE EVENT.