BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212954 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10677
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    February 11, 2013
    Report Date
    July 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES AGREED THAT CIRCUMSTANCES WITH BOTH IMPEDANCES AND PACE THRESHOLDS INCREASING DO NOT FIT THE BEHAVIOR OF CALCIFICATION. TECHNICAL SERVICES FURTHER REVIEWED THE HEADER OF THE DEVICE, BUT NO SIGN OF A COMPROMISED LEAD WAS NOTED. TECHNICAL SERVICES CONFIRMED THAT THE X-RAY IS NOT CONCLUSION FOR TERMINAL PIN INSERTION. A CONNECTION ISSUE WAS NOT SUSPECTED BY THE PHYSICIAN. FURTHER FOLLOW UP WILL BE PERFORMED. AT THIS TIME THE LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT DURING A LEAD REPLACEMENT PROCEDURE THE IMPEDANCES WERE MEASURED OUT OF RANGE AND AN INCREASE IN THRESHOLDS WAS NOTED. THE LEAD WAS ABANDONED AND THE VENOGRAM SHOWED A MOSTLY OCCLUDED VEIN. SEVERAL OPTIONS WERE DISCUSSED FOR RE IMPLANTING THE LEAD BUT AS THE PHYSICIAN WAS NOT TRAINED IN THE PARTICULAR TECHNIQUE THE LEAD COULD NOT BE RE IMPLANTED. NO CHANGE WAS MADE TO THE SYSTEM. THE PHYSICIAN WILL DO FURTHER FOLLOW UP TO ACCESS ON HOW TO PROCEED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A DEVICE IMPLANTED IN 2010, ALL MEASUREMENTS WERE NORMAL UNTIL (B)(6) 2012. THE PATIENT HAD A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE PRIOR BUT SINCE (B)(6) 2012 THERE HAD BEEN A GRADUAL RIDE IN PACING IMPEDANCES AND AN INCREASE IN PACING THRESHOLDS SINCE (B)(6) 2012. THE SHOCK IMPEDANCES WERE STABLE. TECHNICAL SERVICES DISCUSSED A POSSIBLE IMPACT FROM THE ABLATION PROCEDURE OR ELSE THE PHENOMENON OF CALCIFICATION. THE MOST RECENT INFORMATION RECEIVED NOTED THAT A LEAD REVISION WAS PERFORMED, BUT DUE TO THE PATIENT VEINS BEING OCCLUDED PROCEDURE WAS STOPPED BEFORE OPENING THE POCKET. FURTHER DISCUSSED REGARDING THE PATIENT ABLATION PROCEDURE WAS DISCUSSED AS THE PACING IMPEDANCES HAD RISEN SINCE THE MOST RECENT FOLLOW UP TO GREATER THEN 2000 OHMS AND AN INCREASE IN PACING THRESHOLDS WAS ALSO NOTED. THE CAUSE OF THIS BEING DUE TO CALCIFICATION WAS NO LONGER PROBABLY AS BOTH AN INCREASE IN IMPEDANCES AND THRESHOLDS WAS NOTED. ANOTHER INQUIRY WAS MADE TO TECHNICAL SERVICES TO DETERMINE IF IT WOULD BE REASONABLE TO PERFORM A RATE/SENSE LEAD REVISION.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313674 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 0175| 4542| N107| 4480