BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1253611 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40019
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0174 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention THE DEVICE 0184/143542 WAS IMPLANTED 29-AUG-2008| THE DEVICE T175/134582 WAS IMPLANTED 15-JUL-2008