BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953806 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24357
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICE CONSULTANT REVIEWED THE SAVE TO DISK AND DISCUSSED THAT THE PATIENT HAS HAD TACHYCARDIA EPISODES DECLARED AND RECORDED IN THE VT ZONE. HOWEVER, WHEN REVIEWED IT APPEARED THAT THE PATIENT HAD AN ATRIAL FIBRILLATION EPISODE BUT THE DEVICE DECLARED IT AS AN NSVT. THE EGM STORAGE FOR THE COGNIS/TELIGEN DEVICES IS DESIGNED THAT EVENTS ARE STORED WHEN 3 CONSECUTIVE FAST BEATS ARE RECOGNIZED (ABOVE THE PROGRAMMED CUT OFF RATE). THE STORAGE ENDS IF DURATION IS NOT MET AND IF 10 CONSECUTIVE SLOW BEATS ARE NOTED. ATRIAL FIBRILLATION WILL NOT START EGM STORAGE IF ATR IS NOT PROGRAMMED. THE SHOCK IMPEDANCE ON THE RIGHT VENTRICULAR LEAD HAS BEEN SLOWLY RISING AND IS NOW AT 115 OHMS. ALL DAILY MEASUREMENTS ARE STABLE AND WITHIN RANGE WITH THE EXCEPTION OF THE RIGHT VENTRICULAR SHOCK LEAD IMPEDANCE. THE SHOCK LEAD IMPEDANCE IN THE DAILY MEASUREMENTS WAS SLIGHTLY AND GRADUALLY INCREASING WITH OUT OF RANGE MEASUREMENTS IN (B)(6). (>125 OHMS) NO NOISE WAS PRESENT ON THE AVAILABLE EGM AND THE NOISE COULD NOT BE REPRODUCED. THE TRUE SHOCK LEAD IMPEDANCE IS MEASURED EACH TIME A SHOCK IS DELIVERED. IT CAN BE VIEWED ON THE PROGRAMMER ON THE SUMMARY SCREEN FOR THE EVENTS WHERE SHOCKS HAVE BEEN DELIVERED. ALL DELIVERED SHOCKS APPEAR TO BE EFFECTIVE. BECAUSE THE DEVICE APPEARS TO FUNCTION AS INTENDED, IT WAS RECOMMENDED TO CONTINUE MONITORING THE RIGHT VENTRICULAR LEAD. A CONNECTION ISSUE IS UNLIKELY AS NOISE MAY BE EXPECTED ON THE EGM'S (STORED OR REALTIME DURING PROVOCATION TESTS). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THE DEVICE REVEALED STORED TACHYCARDIA EPISODES IN THE VT (VENTRICULAR TACHYCARDIA) ZONE. HOWEVER, WHEN THE EPISODES WERE REVIEWED, IT APPEARED THAT THE PATIENT HAD AN ATRIAL FIBRILLATION EPISODE BUT THE DEVICE DECLARED IT AS AN NON-SUSTAINED VENTRICULAR TACHYCARDIA. IN ADDITION, THE SHOCK IMPEDANCE ON THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD HAD SLOWLY INCREASED TO 115 OHMS. THE PATIENT HAS NOT RECEIVED ANY INAPPROPRIATE THERAPIES. DURING THE FOLLOW UP VISIT, THE PATIENT WAS HAVING RUNS OF SLOW VT. THESE WERE NOT RECORDED BY THE DEVICE AS THE VT'S WERE BELOW THE VT ZONE AT 130BPM AVERAGE. THE PATIENT WAS ASYMPTOMATIC AND EACH RUN LASTED APPROX 5-6 SECONDS. PROVOCATION TESTING INDUCED NO NOISE. PROGRAMMING CHANGES WERE MADE TO THE DEVICE TO ACCOMMODATE FOR THE VT. THE LEAD REMAINS IMPLANTED AND THE SHOCK IMPEDANCES WILL BE MONITORED CLOSELY. A SAVE TO DISK WAS PERFORMED AND SENT TO A BOSTON SCIENTIFIC TECHNICAL CONSULTANT FOR REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Other