BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1871879 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17595
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD INDICATING THE PATIENT WILL CONTINUE TO BE MONITORED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ATRIAL PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THERE WAS NO EVIDENCE OF NOISE. TECHNICAL SERVICES DISCUSSED THE OPTIONS OF CONTINUED MONITORING, DEVICE REPROGRAMMING TO VVI, OR REPLACING THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR (B)(4)| A155| 0158| E110