BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210288 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07422
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION CONFIRMED THE LEAD WAS RETURNED IN SEGMENTS AND THE THE DAMAGE ON THE LEAD APPEARS TO BE RELATED TO THE EXPLANT PROCEDURE. TESTING DID NOT IDENTIFY ANY LEAD ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLININCAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT HIGH VOLTAGE (HV) IMPEDANCE MEASUREMENTS WITH THIS LEAD HAD INCREASED TO GREATER THAN 200 OHMS. HOWEVER, THE PATIENT HAD RECEIVED A STENT AND MEASUREMENTS HAD BEEN STABLE SINCE THAT PROCEDURE. MOST RECENTLY, A POCKET REVISION WAS PERFORMED TO PERFORM LEAD TESTING. THE PHYSICIAN REMOVED BOTH THE PROXIMAL AND THE DISTAL COILS AND HIGH VOLTAGE IMPEDANCE MEASUREMENTS WERE PERFORMED. THE MEASUREMENTS WERE WITHIN NORMAL LIMITS (49-57 OHMS) IN ALL SIX VECTORS. THE LEAD REMAINS IN SERVICE AND THE PHYSICIAN PLANS TO CONTINUE TO MONITOR THIS PATIENT. A WHITE PURULENT DRAINAGE WAS NOTED AT THE PROCEDURE AND A BLOOD CULTURE WILL BE PERFORMED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND THE POSSIBLE REASONS FOR THE OUT OF RANGE MEASUREMENTS. A REVIEW OF THE CURRENT MEASUREMENTS CONFIRM THEY ARE WITHIN NORMAL LIMITS. ACCORDING TO OUR RESOURCES, THE LEAD REMAINS IN SERVICE AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED TO CHECK THIS SYSTEM AND WHEN THE POCKET WAS OPENED, THE PHYSICIAN NOTED THE PATIENT WAS DEVELOPING AN INFECTION. THEREFORE, THE ENTIRE SYSTEM WAS EXPLANTED AND THE PATIENT IS BEING TREATED WITH ANTIBIOTICS. A NEW SYSTEM WILL BE IMPLANTED WHEN THE INFECTION IS GONE. THIS LEAD HAS BEEN RETURNED FOR TESTING AND THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXHIBITING HIGH (OUT OF RANGE) PACING AND SHOCKING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311788 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R E110| 0158| 5076