BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905762 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11635
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 18, 2014
    Report Date
    June 27, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE AND LEAD WERE LATER EXPLANTED AND REPLACED. IT WAS ALSO NOTED THAT THIS LEAD HAD EXHIBITED INCREASED PACING THRESHOLD MEASUREMENTS AT THE TIME OF THE DEVICE REPLACEMENT PROCEDURE; THEREFORE, AT THAT TIME, THE RATE/SENSE PORTION OF THE LEAD WAS SURGICALLY ABANDONED AND A NEW RV PACING LEAD WAS IMPLANTED. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS NOTED TO BE SEVERED 140MM FROM THE TERMINAL PIN. TWO SEGMENTS WERE RETURNED THAT MEASURED 630MM IN TOTAL, INDICATING A 10MM PORTION OF THE LEAD WAS MISSING. AN EXTRACTING STYLET WAS INSERTED INTO THE TIP SEGMENT, AND SIGNIFICANT EXPLANT DAMAGE WAS OBSERVED ON BOTH LEAD SEGMENTS, INCLUDING STRETCHED CONDUCTOR COILS AND TORN AND CUT INSULATION. TISSUE AND CALCIFICATION WERE ADHERED TO THE PROXIMAL AND DISTAL SHOCKING COILS, AND THE CALCIFICATION WAS ALSO NOTED ON THE HELIX. THE HELIX WAS EXTENDED. ELECTRICAL CONTINUITY TESTING WAS PERFORMED ON THE RETURNED LEAD SEGMENTS, AND ALL PATHWAYS WERE CONFIRMED TO BE ELECTRICALLY CONTINUOUS. NO CONDUCTOR FRACTURES WERE OBSERVED. LABORATORY ANALYSIS CONCLUDED THAT THE BUILD-UP OF CALCIFICATION ON THE SHOCKING COILS HAD CREATED A NON-CONDUCTIVE BARRIER, CAUSING THE SHOCK IMPEDANCE MEASUREMENTS TO GRADUALLY INCREASE OVER TIME. DUE TO THE CONDITION OF THE RETURNED LEAD, MANUAL IMPEDANCE TESTING WAS NOT ABLE TO BE PERFORMED; HOWEVER, PREVIOUS LABORATORY TESTING ON LEADS WITH SIMILAR CALCIFICATION FOUND THAT AS THE CALCIFIED MATERIAL IS REMOVED, THE IMPEDANCE MEASUREMENTS DECREASE. IT WAS SUSPECTED THE CALCIFIED MATERIAL ON THE HELIX HAD CAUSED THE INCREASE IN PACING THRESHOLD MEASUREMENTS THAT HAD BEEN OBSERVED DURING THE DEVICE REPLACEMENT PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE AND LEAD REMAIN IN SERVICE, PENDING THE REPLACEMENT PROCEDURE. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE FOLLOW-UP, A REVIEW OF THE LEAD DAILY MEASUREMENTS SHOWED THIS RIGHT VENTRICULAR (RV) LEAD HAD TWO OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS THAT WERE GREATER THAN 200 OHMS. NO OTHER ISSUES WERE NOTED, AND NO CHANGES WERE MADE TO THE SYSTEM AT THIS TIME. LATER, THE PATIENT WAS SEEN AGAIN SO ADDITIONAL SHOCK IMPEDANCE TESTING COULD BE PERFORMED. ALSO, A COPY OF THE DEVICE DATA WAS SAVED TO A DISK AND SUBMITTED TO TECHNICAL SERVICES FOR EVALUATION. UPON ENGINEERING REVIEW OF THE DEVICE DATA, IT WAS CONFIRMED THAT THE SHOCK IMPEDANCE MEASUREMENTS WERE HIGH, OUT-OF-RANGE IN ALL SHOCK CONFIGURATIONS. NO NOISE WAS OBSERVED, AND IT WAS REPORTED THAT AN X-RAY SHOWED NO VISIBLE LEAD DAMAGE. TECHNICAL SERVICES DISCUSSED THE DATA POINTED TO A POTENTIAL LEAD PROBLEM, BUT THERE WAS NOT ENOUGH EVIDENCE TO RULE OUT A DEVICE ISSUE; THEREFORE, IT WAS RECOMMENDED TO REPLACE BOTH THE LEAD AND THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383556 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR T167| E143| 0185| 4096