BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1771410 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12591
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC, CRM WILL ANALYZE THIS DEVICE UPON RECEIPT AND PROVIDE ADDITIONAL INFORMATION ONCE THE TESTING HAS BEEN COMPLETED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO ADDITIONAL INFORMATION WE RECEIVED FROM THE REP, THE NOISE APPEARS CONSISTENTLY ON THE RV CHANNEL ONLY - THE RV LEAD WAS MANUFACTURED BY A COMPETITOR - AND ALL THREE LEADS ARE IMPLANTED SUBCLAVIAN. ALTHOUGH IT HAS NOT BEEN VERIFIED, THE DEVICE IS SUSPECTED TO HAVE BEEN IMPLANTED SUBPECTORALLY. ALSO, ACCORDING TO TECHNICAL SERVICES THE TYPE OF NOISE IS CONSISTENT WITH TRANSIENT NON-CARDIAC SIGNALS. ALTHOUGH A HEADER ISSUE CANNOT BE EXCLUDED, THERE IS MORE EVIDENCE OF AN RV LEAD CONNECTION ISSUE OR CONDUCTOR FRACTURE. AND FURTHER INVASIVE ASSESSMENT AND CORRECTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IS SCHEDULED TO BE EXPLANTED DUE TO OBSERVATIONS THE PHYSICIAN RELATES TO AN ISSUE WITH THE DEVICE HEADER. THE OBSERVATIONS WERE: INCREASED RV PACING IMPEDANCE (500 OHMS (B)(6) 2010; 1278 OHMS (B)(6) 2010); INCREASED LV IMPEDANCE (768 OHMS IN (B)(6) TO 1671 OHMS IN (B)(6)); INCREASED PACING THRESHOLD (NO RV OR RA PACING AT MAXIMUM OUTPUT OF 7V); NOISE (MOVEMENT OF THE PATIENT'S LEFT ARM/SHOULDER WAS RECORDED AS NOISE AND INTERPRETED AS VENTRICULAR FIBRILLATION) RESULTING IN THE PATIENT RECEIVING NUMEROUS INAPPROPRIATE SHOCKS. ALSO, THE LEADS WERE X-RAYED AND NO FRACTURE WAS APPARENT. THE DEVICE IMPLANT ORIENTATION IS UNKNOWN. TACHY THERAPY WAS DISABLED AND THE PATIENT WAS HOSPITALIZED FOR THE UPCOMING EXPLANT PROCEDURE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND M177

    Patients

    Seq Age Sex Outcome Treatment
    1