BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1254251 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40854
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention THE DEVICE 4542/123282 WAS IMPLANTED 11-AUG-2008| THE DEVICE H227/561221 WAS IMPLANTED 11-AUG-2008| THE DEVICE 0185/169107 WAS IMPLANTED 22-SEP-2008| THE DEVICE 7120 AHA198 WAS USED DURING THE EVENT.| THE DEVICE 4470/601450 WAS IMPLANTED 11-AUG-2008