BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3223529 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10251
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 4, 2013
    Report Date
    October 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION REVEALED AN INSULATION SLEEVE BUNCHED IN SEVERAL PLACES. THE SILICONE ABRASION SLEEVE WAS ABRADED THROUGH TO THE POLY INSULATION SLEEVE APPROXIMATELY 85 TO 87 MM FROM THE TERMINAL PIN; HOWEVER, THE POLY ABRASION SLEEVE UNDERNEATH IT WAS INTACT. THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION AND BLOOD/BODY FLUID WAS NOTED IN THE RATE SENSE (RS) LUMEN AS WELL IN THE HELIX HOUSING. THE HELIX WAS NOTED TO BE RETRACTED. A CONTINUITY TEST WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE WHICH PRODUCED NORMAL MEASUREMENTS. DETAILED ANALYSIS REVEALED A DAMAGED TRILUMEN INSULATION 390 TO 404 MM FROM THE TERMINAL PIN TO THE RS LUMEN. THE POLYTETRAFLUOROETHYLENE WAS ABRADED/TORN IN THIS AREA AS WELL. FURTHER, TRIMULEN INSULATION WEBBING DAMAGE WAS NOTED BETWEEN THE RS AND DISTAL HIGH VOLTAGE LUMENS. THE LEAD INSULATION IN THIS AREA WAS FLATTENED. MICROSCOPIC ANALYSIS INDICATED THAT THE INSULATION DAMAGE WAS INITIATED BY A LOCALIZED COMPRESSION STRESS ON THE TUBING SURFACE. IT WAS CONCLUDED THAT THE INSULATION DAMAGE WAS MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE/FIRST RIB REGION BASED ON THE LOCATION AND TYPE OF DAMAGE. NO FURTHER ISSUES WERE OBSERVED.

    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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LOW PACING IMPEDANCE WAS OBSERVED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD THROUGH THE REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION INDICATED THAT THE ABNORMAL IMPEDANCE MEASUREMENTS WERE SUSPECTED TO BE DUE TO INSULATION ISSUES WITH THE LEAD. MORE FREQUENT PATIENT MONITORING WAS PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE RV LEAD WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321803 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1