BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042389 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34260
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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 0164 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE DEVICE 4470/433766 WAS IMPLANTED 26-AUG-2004| THE DEVICE 4470/ WAS IMPLANTED| THE DEVICE 0185/191725 WAS IMPLANTED 26-MAR-2008| THE DEVICE 6481 304096 WAS USED DURING THE EVENT.| THE DEVICE T165/108630 WAS IMPLANTED 08-JUN-2005