BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1042619 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34014
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 53 YR Other THE DEVICE 4053/406130 WAS IMPLANTED 10-APR-2001| THE DEVICE 5024 LAT047 WAS USED DURING THE EVENT.