BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1043095 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33540
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    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 74 YR Required Intervention THE DEVICE 6483 506020 WAS USED DURING THE EVENT.| THE DEVICE 6487 506020 WAS USED DURING THE EVENT.| THE DEVICE 6482 012258 WAS USED DURING THE EVENT.| THE DEVICE 4087/268539 WAS IMPLANTED 27-DEC-2006| THE DEVICE 1174/109469 WAS IMPLANTED 14-JUN-1999| THE DEVICE H217/705131 WAS IMPLANTED 27-DEC-2006| THE DEVICE 4035/214138 WAS IMPLANTED 14-JUN-1999| THE DEVICE 4538/158153 WAS IMPLANTED 27-DEC-2006