BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1253951 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40697
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 63 YR Other THE DEVICE 6482 008810 WAS USED DURING THE EVENT.| THE DEVICE 4543/119433 WAS IMPLANTED 07-JUL-2006| THE DEVICE H217/701803 WAS IMPLANTED 07-JUL-2006| THE DEVICE 4470/514489 WAS IMPLANTED 07-JUL-2006