BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1771376 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12431
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 16, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED SUGGESTED THAT THE LEAD IS A BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OUT OF RANGE SHOCKING IMPEDANCES AS WELL AS NOISE WERE NOTED ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AT A FOLLOW UP IN (B)(6) 2009. THE ERROR MESSAGE WAS CLEARED AND NORMAL SHOCKING IMPEDANCES WERE SEEN. THE PATIENT WAS RELEASED. THE MOST RECENT INFORMATION RECEIVED NOTED THAT OUT OF RANGE SHOCKING IMPEDANCES WERE ONCE AGAIN DETECTED. THE PATIENT WAS ADMITTED TO THE DOCTORS OFFICE. THE ERROR MESSAGE WAS ONCE AGAIN CLEARED AND A HIGH ENERGY SHOCK WAS ADMINISTERED. INDUCTION TESTING WAS SUCCESSFUL AND THE SHOCKING IMPEDANCES WERE BACK WITHIN NORMAL RANGE. IT WAS ALSO NOTED THAT AMPLITUDES HAD BEEN FLUCTUATING. EVALUATION OF THE SAVE TO DISK BY TECHNICAL SERVICES REVEALED THAT THE CLINICAL OBSERVATION WAS MOST LIKELY RELATED TO A LEAD ISSUE. A POSSIBLE LEAD FRACTURE WAS DISCUSSED. THE LEAD MODEL/SERIAL AND MANUFACTURER IS UNKNOWN AT THE TIME. THE DEVICE REMAINS IMPLANTED AND A REVISION WAS PLANNED AS THE DEVICE IS CURRENTLY AT MIDDLE OF LIFE 2 (MOL2). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1