BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1962286 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00943
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 20, 2010
    Report Date
    May 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED AND WILL CONTINUE TO BE MONITORED. 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

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS EXPLANTED DURING A SCHEDULED DEVICE REPLACEMENT PROCEDURE. THE LEAD WAS RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE LEAD WAS RETURNED SEVERED, 110 AND 152MM FROM THE TERMINAL PIN. 3 SEGMENTS OF THIS LEAD WERE RETURNED, TOTAL LENGTH ¿ APPROXIMATELY 590MM. THE LEAD SEGMENTS PASSED ELECTRICAL TESTING AND A FRACTURE COULD NOT BE CONFIRMED ON EITHER RETURNED SEGMENT ON X-RAY. THERE WAS RESIDUAL CALCIFICATION MATERIAL NOTED ON THE LEAD TIP. A SYMPTOM OF INCREASING CALCIFICATION ON THE LEAD¿S MESH TIP IS A GRADUAL RISE IN IMPEDANCE MEASURED BY THE DEVICE OVER TIME. THE DEVICE THIS LEAD WAS RETURNED WITH SHOWS IMPEDANCE MEASUREMENTS GRADUALLY RISING FROM APPROXIMATELY 1000 OHMS TO OVER 3000 OHMS IN THE PAST FEW YEARS. ALTHOUGH THERE IS ONLY RESIDUAL CALCIFIED BODY FLUID NOTED ON THE MESH TIP, CALCIFIED BODY FLUID MAY HAVE BUILT UP ON THE LEAD MESH TIP CREATING A NON-CONDUCTIVE BARRIER BETWEEN THE LEAD MESH TIP AND THE PATIENTS HEART TISSUE, THEREBY INCREASING THE IMPEDANCE SEEN BY THE DEVICE GRADUALLY AS THE CALCIFICATION INCREASED. PRIOR TESTING HAS SHOWN THAT AS THE CALCIFIED MATERIAL IS REMOVED, THE IMPEDANCE DROPS.

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED. 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

    OUR COMPANY RECEIVED ADDITIONAL INFORMATION THAT THIS DEFIBRILLATION LEAD DISPLAYED HIGH THRESHOLD MEASUREMENTS. IT WAS REPORTED THAT IN THE PAST NOISE WAS OBSERVED ON THE PACE SENSE AND SHOCKING CHANNEL. A TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED ADDITIONAL TESTING. THE CONSULTANT ALSO DISCUSSED THE POTENTIAL OF THE LEAD PINS BEING REVERSE IN THE DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    OUR COMPANY HAS RECEIVED ADDITIONAL INFORMATION EIGHT MONTHS LATER THAT THIS RIGHT VENTRICULAR LEAD CONTINUES TO DISPLAY HIGH PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEFIBRILLATION LEAD DISPLAYED A PACE SENSE IMPEDANCE GREATER THAN 2500 OHMS. THERE WAS NO NOISE OR INAPPROPRIATE SHOCK DELIVERED. A TECHNICAL SERVICES CONSULTANT WAS CONTACTED AND RECOMMENDED ISOMETRICS AND POCKET MANIPULATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR H210| 5076| 0174| 4554