BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1253892 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40701
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS
    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 0184 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE DEVICE T125/124006 WAS IMPLANTED| THE DEVICE 4480/ WAS IMPLANTED