BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 605718 · Received February 10, 2005

    Report

    Report Number
    2124215-2005-09047
    Event Type
    Malfunction
    Date Received
    February 10, 2005
    Date of Event
    October 14, 2004
    Report Date
    October 14, 2004
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE TRANSVENOUS DEFIBRILLATION LEAD WAS EXPLANTED WHEN IT EXHIBITED LOSS OF VENTRICULAR CAPTURE DUE TO HIGH PACING THRESHOLDS. THE STATUS OF THE PATIENT HAD CHANGED SUCH THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UPGRADED TO A BI-VENTRICULAR DEVICE. THE CLINICIAN HAS ASKED TO CONSIDER PATIENT FOR UNREIMBURSED MEDICAL.,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other