BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1254223 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-41058
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention THE DEVICE 4555/168737 WAS IMPLANTED 18-AUG-2008| THE DEVICE 3120 WAS USED DURING THE EVENT.| THE DEVICE 4087/239482 WAS IMPLANTED 10-JUN-2005| THE DEVICE N119/000885 WAS IMPLANTED 18-AUG-2008