BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1253759 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40611
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 15, 2008
    Report Date
    May 3, 2012
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NVY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A TS CONSULTANT REVIEWED THE PRINTOUTS AND DISCUSSED THAT THE GRADUAL INCREASE IN PACING IMPEDANCE MEASUREMENTS, WITH ALL OTHER LEAD MEASUREMENTS REMAINING STABLE, COULD BE EITHER DUE TO CALCIUM DEPOSITS BUILT UP ON THE ELECTRODE TIP OR A POLARIZATION EFFECT AROUND THE ELECTRODES AS THE PATIENT IS NOT PACED OFTEN. THE INTERMITTENT NOISE ON THE ELECTROGRAMS THAT WAS OBSERVED DURING HIGH OUTPUT PACING WAS OVERSENSED BUT ONLY ONE SIGNAL. AS THE NOISE WAS NOTED DURING THE HIGH OUTPUT PACING, IT IS MORE LIKELY THAT THE HIGH IMPEDANCE VALUES COULD BE DUE TO POLARIZATION AROUND THE ELECTRODES. HOWEVER, A LEAD INTEGRITY ISSUE OR POSSIBLE DEVICE/HEADER ISSUE COULD NOT BE RULED OUT. IN ADDITION, THERE WAS A REQUEST TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO PERFORM A DATA REVIEW FROM THE REMOTE MONITORING SYSTEM. IT WAS DISCUSSED THAT THE RV PACING IMPEDANCE DAILY MEASUREMENTS HAVE BEEN TURNED OFF SINCE (B)(6) 2011. PRIOR TO THIS, THE IMPEDANCE MEASUREMENT HAD BEEN ABOVE 2,000 OHMS. SHOCK IMPEDANCE MEASUREMENTS HAVE REMAINED STABLE. THE PATIENT APPEARS TO BE 100% SENSED AND SENSING APPEARS STABLE. THE TS CONSULTANT DISCUSSED SEVERAL TROUBLESHOOTING TECHNIQUES, INCLUDING COMMANDED SHOCK DELIVERY, SHOULD BE CONSIDERED TO HELP DETERMINE IF THERE IS A LEAD OR DEVICE ISSUE. AT THIS TIME, THIS RV LEAD AND ICD REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ONCE ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A REVISION PROCEDURE, THIS IMPLANTABLE RIGHT VENTRICULAR DEFIBRILLATION LEAD HAD PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS AS MEASURED BY THE PACING SYSTEM ANALYZER (PSA). NO ADVERSE PATIENT EFFECTS WERE REPORTED. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED THAT THE LEAD BE REPLACED. THE PHYSICIAN DECIDED TO MONITOR THE LEAD AND REPLACE IT IF THE CONDITION DETERIORATES. ADDITIONAL INFORMATION WAS REPORTED THAT OVER THREE YEARS LATER DURING A PATIENT FOLLOW UP, NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR CHANNEL THAT WAS OVERSENSED; HOWEVER, THE NOISE WAS ONLY WHEN THE DEVICE WAS PROGRAMMED TO A HIGH PACING OUTPUT. POCKET MANIPULATION TESTING WAS PERFORMED AT NORMAL OUTPUTS AND THE NOISE WAS UNABLE TO BE REPRODUCED. THE PACING IMPEDANCE MEASUREMENTS HAVE REMAINED ABOVE 2,000 OHMS SINCE THE IMPLANT OF THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), BUT ALL OTHER LEAD MEASUREMENT HAVE REMAINED STABLE. THE ICD IS IMPLANTED SUBPECTORALLY AND IS PART OF THE SUBPECTORAL IMPLANT ADVISORY, COMMUNICATED ON (B)(4) 2009. THERE IS A CONCERN THAT THERE MAY BE AN ISSUE WITH THE DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. PRINTOUTS WERE SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CARDIAC PACEMAKERS, INC 0148 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R THE DEVICE 4480/429176 WAS IMPLANTED 01-FEB-2005| THE DEVICE (B)(4)| THE DEVICE F110/000445 WAS IMPLANTED 15-SEP-2008| THE DEVICE (B)(4)