BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1043276 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33357
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 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 HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention THE DEVICE 4520/200321 WAS IMPLANTED 12-OCT-2004| THE DEVICE 6481 026483 WAS USED DURING THE EVENT.| THE DEVICE 0158/144014 WAS IMPLANTED 12-OCT-2004| THE DEVICE H175/506769 WAS IMPLANTED 12-OCT-2004