BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042927 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33708
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 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 G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0184 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention THE DEVICE 6487 507030 WAS USED DURING THE EVENT.| THE DEVICE 4518/327509 WAS IMPLANTED 22-JUN-2007| THE DEVICE H215/707940 WAS IMPLANTED 22-JUN-2007| THE DEVICE 6483 507070 WAS USED DURING THE EVENT.| THE DEVICE 6482 026955 WAS USED DURING THE EVENT.