BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3211349 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07909
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 13, 2009
    Report Date
    May 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE, THE INSULATION ON THE IS-1 PORTION OF THIS RIGHT VENTRICULAR (RV) LEAD WAS REPAIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. OVER TWO YEARS LATER, THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A PACING IMPEDANCE MEASUREMENT ABOVE 2,000 OHMS ON THIS RV LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND REVIEWED THE DATA. THE TS CONSULTANT DISCUSSED THAT THERE WAS ONE MEASUREMENT ABOVE 2,000 OHMS BUT ALL OTHER MEASUREMENTS HAVE BEEN IN NORMAL RANGE. THERE WAS NO NOISE ON THE ELECTROGRAMS (EGMS). IN ADDITION, IT APPEARED THAT THERE WERE SEVERAL INCREASES IN PACING IMPEDANCE MEASUREMENTS OVER THE PAST 18 MONTHS WITH LONG PERIODS OF STABLE MEASUREMENTS IN BETWEEN. THE TS CONSULTANT DISCUSSED PERFORMING ISOMETRICS WHILE PERFORMING IMPEDANCE MEASUREMENTS TO FURTHER EVALUATE THE LEAD. ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE CLINIC FOR EVALUATION. DESPITE ISOMETRICS AND POCKET MANIPULATION, THE OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS UNABLE TO BE REPRODUCED. THE SENSING AND PACING THRESHOLD MEASUREMENTS HAD ALSO REMAINED STABLE AND CONSISTENT. IN ADDITION, A REVIEW OF THE ARRHYTHMIA LOGBOOK FOUND THAT THERE WERE NO STORED EPISODES SHOWING MYOPOTENTIAL OVERSENSING. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD AND RV LEAD REMAIN IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309425 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 1793| 0154| T175