BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 750790 · Received August 9, 2006

    Report

    Report Number
    2124215-2006-15005
    Event Type
    Injury
    Date Received
    August 9, 2006
    Date of Event
    April 25, 2006
    Report Date
    April 25, 2006
    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

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE LEAD, WHICH WAS IMPLANTED ONE DAY EARLIER WITH GOOD LEAD VALUES, DISPLAYED LOW IMPEDANCE,A HIGH PACING THRESHOLD AND 1.5 MV R-WAVE MEASUREMENT. ON FLOUROSCOPY THE LEAD APPEARED TO HAVE PULLED BACK. AN INVASIVE PROCEDURE WAS DONE AND THE LEAD WAS SUCCESSFULLY REPOSITONED.

    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 UNKNOWN Required Intervention