BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1944945 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-21274
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    November 9, 2009
    Report Date
    November 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS SUBSEQUENTLY RETURNED. VISUAL INSPECTION NOTED THAT ALL SETSCREWS MOVED FREELY AND DID NOT REVEALED ANY CROSS-THREADING. A REVIEW OF THE DAILY LEAD IMPEDANCES MEASUREMENTS FOUND THAT VARYING RIGHT VENTRICULAR WERE WITHIN NORMAL RANGE. THE DEVICE PASSED AUTOMATED ELECTRICAL TESTING WHICH VERIFIED PACING, SENSING, DEFIBRILLATION, LEAD IMPEDANCE CIRCUITRY, AND RECORDED FUNCTIONS.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, THE ICD ALONG WITH THE LEADS WAS EXPLANTED. NO ANOMALIES WERE NOTED WHEN DISCONNECTING THE LEADS AND NO HEADER DAMAGED WAS CONFIRMED. AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PRECEEDING THE REPLACEMENT OF A PREVIOUSLY IMPLANTED DEVICE TO THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING AND FLUCTUATING IMPEDANCES ON THE RIGHT VENTRICULAR CHANNEL. NO DAMAGE ON THE RIGHT VENTRICULAR LEAD WAS NOTED. AT A FOLLOW UP A NON SUSTAINED VENTRICULAR FIBRILLATION EPISODE WAS PRESENT AS WELL AS FLUCTUATING PACING IMPEDANCES. A SAVE TO DISK AS WELL AS INFORMATION FROM LATITUDE WAS OBTAINED BY TECHNICAL SERVICES FOR ANALYSIS. NOISE WAS SEEN ON THE RIGHT VENTRICULAR CHANNEL AS WELL AS FLUCTUATING IMPEDANCES. A CD CONTAINING X-RAYS WAS ALSO ANALYZED BY ENGINEERS AND TECHNICAL SERVICES. THE X-RAYS REVEALED THAT THE TERMINAL PINS OF THE LEAD APPEARED TO BE INSERTED ALL THE WAY INTO THE HEADER AND THE SETSCREWS APPEARED TO BE IN THE DOWN (TIGHTENED POSITION). IN ADDITION TECHNICAL SERVICES DISCUSSED THE FACT THAT THIS PATIENT WAS IMPLANTED WITH A COMPETITOR BIPOLAR LEAD AND IF COILS OF THE TWO LEADS MAKE CONTACT WITH ONE ANOTHER, INTERMITTENT NOISE IS ALSO A POSSIBLE OUTCOME. AN INVASIVE PROCEDURE WAS PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1