BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043333 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02005
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 22, 2013
    Report Date
    September 14, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED AND WAS SUCCESSFULLY INTERFACED TO THE REPLACEMENT DEVICE. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DETAILS WERE RECEIVED THREE YEARS AFTER THE INITIAL OBSERVATIONS WERE REPORTED THAT THIS SYSTEM WAS STILL EXHIBITING OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS. THE CALLER STATED THEY WOULD CONTINUE TO MONITOR THE PATIENT. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND WHAT TESTING COULD BE PERFORMED. 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

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS PATIENT WAS BEING FOLLOWED BY ANOTHER CLINIC; HOWEVER, THAT CLINIC WOULD NOT PERFORM A REPLACEMENT PROCEDURE SO THIS PATIENT TRANSFERRED TO ANOTHER CLINIC. THE PATIENT WAS BROUGHT IN FOR SYSTEM EVALUATION DUE TO THE EARLY BATTERY DEPLETION ALERT, WHICH COULD BE RELATED TO FAULT CODE (1003) AND THE CONTINUED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. ADDITIONALLY, THERE HAVE BEEN CHRONIC LOW PACING IMPEDANCE AND SENSING MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) CHANNEL AND ELEVATED THRESHOLDS. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE AND RV LEAD WERE REMOVED FROM SERVICE AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXHIBITING INCREASING SHOCK IMPEDANCE MEASUREMENTS WHICH WERE NOW GREATER THAN 125 OHMS. THIS PATIENT IS HAVING AN ELECTIVE DEVICE CHANGEOUT AND THE CALLER WAS INQUIRING ABOUT TESTING TO ENSURE THE INTEGRITY OF THE SYSTEM. A BOSTON SCIENTIFIC SALES REPRESENTATIVE CONFIRMED SUCCESSFUL DEFIBRILLATION THRESHOLD TESTING (DFT) WITH NO UNDERSENSING AT 21J AND THE SHOCK IMPEDANCE WAS 115 OHMS. 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
    145596 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R T177