BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1852652 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14422
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 5, 2006
    Report Date
    July 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Removal / Correction Number
    Z-0863-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAST REMOTE INTERROGATION FOR THIS DEVICE SHOWED SHOCK IMPEDANCE DAILY MEASUREMENTS AGAIN BETWEEN 49 OHMS AND 123 OHMS. THE PHYSICIAN WAS COMFORTABLE WITH THE LEAD'S ABILITY TO DELIVER THERAPY BASED ON THE (B)(6) 2006 (B)(6) STUDY. THE DEVICE AND LEAD REMAIN IN SERVICE WITHOUT FURTHER COMPLICATION. SHOULD BOSTON SCIENTIFIC RECEIVE ADDITIONAL INFORMATION RELATED TO THIS CLINICAL OBSERVATION, THIS EVENT WILL BE REOPENED AND UPDATED. BOSTON SCIENTIFIC RECEIVED NEW INFORMATION THAT THIS PATIENT HAD CHANGED PHYSICIANS AND THE NEW CLINIC WAS REQUESTING INFORMATION ABOUT THE PAST SHOCK IMPEDANCE ISSUE. DAILY MEASUREMENTS WERE AGAIN REACHING UP TO 124 OHMS BUT WERE NEVER OUT OF RANGE. TECHNICAL SERVICES DISCUSSED THE PREVIOUS CALLS AND AGAIN RECOMMENDED TESTING THE SYSTEM WITH A MINIMUM AND MAXIMUM ENERGY SHOCK IF THE PHYSICIAN WANTED TO CONFIRM SHOCK THERAPY. THE FIELD REPRESENTATIVE PLANNED TO DISCUSS THE ISSUE WITH THE NEW PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS LATER REPORTED THAT DURING THE DEVICE REPLACEMENT PROCEDURE, THE CONNECTIONS ON THE LEAD WERE TESTED. WHEN THE PHYSICIAN TUGGED ON THE PROXIMAL LEG, THE LEAD PULLED OUT EASILY. IT WAS EXPECTED THAT THE LOOSE CONNECTION WAS RESPONSIBLE FOR THE FLUCTUATING SHOCK IMPEDANCE MEASUREMENTS. THE LEAD WAS TESTED WITH THE NEW DEVICE AND NORMAL MEASUREMENTS WERE NOTED. DFT TESTING ALSO PRODUCED NORMAL MEASUREMENTS. THE LEAD REMAINS IN SERVICE WITH THE NEW DEVICE. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND ASSOCIATED TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED ELEVATED SHOCK IMPEDANCE MEASUREMENTS. THE LAST MEASUREMENT WAS 69 OHMS, BUT MEASUREMENTS OF 122 OHMS AND 59 OHMS HAD ALSO BEEN SEEN. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED A POTENTIAL LOOSE SETSCREW, THEN SUGGESTED MAXIMUM ENERGY SHOCKS TO EVALUATE THE LEAD INTEGRITY IF THE SETSCREW WAS NOT FOUND TO BE LOOSE. IT WAS LATER REPORTED THAT THE PATIENT SAW THE EP AND NORMAL SHOCK IMPEDANCES WERE PRODUCED. THE PATIENT RECEIVED FIVE 41 JOULE SHOCKS IN OCTOBER AND IMPEDANCES THEN WERE 42-44 OHMS. IT WAS LATER REPORTED THAT THE SHOCK IMPEDANCE WAS AGAIN AT 122 OHMS. TS AGAIN RECOMMENDED DELIVERY OF MINIMUM AND MAXIMUM ENERGY SHOCKS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A NON-INVASIVE EP STUDY. THE SHOCKING LEAD IMPEDANCE TESTED WITHIN NORMAL LIMITS, AT 40 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 0184| H219| 4517| 4086