BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 605649 · Received February 10, 2005

    Report

    Report Number
    2124215-2005-09108
    Event Type
    Malfunction
    Date Received
    February 10, 2005
    Date of Event
    October 29, 2004
    Report Date
    November 3, 2004
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CORONARY SINUS TRANSVENOUS IMPLANTABLE LEAD EXPERIENCED DIAPHRAGMATIC STIMULATION A FEW DAYS POST-IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED THAT BOTH THIS LEAD AS WELL AS THE VENTRICULAR IMPLANTABLE LEAD WERE EXPLANTED A FEW DAYS POST-IMPLANT. THIS LEAD CONTINUALLY DISLODGED. THE VENTRICULAR IMPLANTABLE LEAD EXHIBITED LOSS OF CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G * LWS CARDIAC PACEMAKERS, INC 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other