BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1945527 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19882
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    December 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AN X-RAY WAS PERFORMED AND REVEALED THE RATE/SENSE (R/S) PIN WAS NOT FULLY INSERTED PAST THE CONNECTOR BLOCK. THE POCKET WAS OPENED AND THIS WAS CONFIRMED. THE PIN WAS UNABLE TO BE REMOVED FROM THE DEVICE WITHOUT UNSCREWING THE SETSCREW. ATTEMPTS WERE MADE TO REINSERT THE RV R/S PIN INTO THE HEADER BUT RESISTANCE WAS MET AND THE PIN KEPT PUSHING BACK. THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. THE CHRONIC LEAD WAS ABLE TO BE FULLY INSERTED INTO THE NEW HEADER WITH EASE. THE DEVICE WILL BE RETURNED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. GAUGE PIN MEASUREMENTS OF THE LEAD BARRELS AND TERMINAL BLOCKS WERE WITHIN NORMAL LIMITS. A LEAD WAS SUCCESSFULLY INSERTED INTO EACH LEAD BARREL WITH MINIMAL DIFFICULTY. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PACE IMPEDANCE WAS AGAIN OUT OF RANGE. NOISE WAS REPRODUCIBLE. TACHY THERAPY WAS DEACTIVATED AND THE PLAN MOVING FORWARD HAD NOT BEEN DETERMINED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT A LEAD FRACTURE WAS SUSPECTED. THE LEAD WILL BE REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A RED ALERT WAS ISSUED FOR THIS DEVICE INDICATING HIGH RIGHT VENTRICULAR (RV) PACE IMPEDANCE. PACE IMPEDANCE HAS BEEN STABLE AROUND 500 OHMS SINCE IMPLANT AND THEN MEASURED > 2000 OHMS FOR TWO DAILY MEASUREMENTS AND THE FOLLOWING DAY WAS BACK DOWN TO 456 OHMS. SHOCK IMPEDANCE HAS GONE FROM 50-65 OHMS SINCE IMPLANT. TECHNICAL SERVICES (TS) DISCUSSED THAT THE RISE IN SHOCK IMPEDANCE WAS GRADUAL SO THERE WAS NO CONCERN FOR A CONNECTION OR LEAD ISSUE. TS DISCUSSED THAT MOST LIKELY THERE IS A CONNECTION ISSUE WITH THE RV RATE/SENSE (R/S) PORTION OF THE LEAD (IS-1 TERMINAL). THERE HAVE ALSO BEEN MANY NON-SUSTAINED EPISODES WITH NOISE ON THE RV R/S CHANNEL AND THERE WAS ALSO SOME NOISE ON THE SHOCK CHANNEL. TS DISCUSSED THE NOISE ON THE SHOCK CHANNEL COULD BE NORMAL AND SUGGESTED TRYING TO RECREATE THE NOISE. THE REPRESENTATIVE WILL DISCUSS WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    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 45 YR Required Intervention 0180| E110| T125| 4470| 0185