BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140012 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16737
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE BEING MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS BROUGHT INTO THE CLINIC AND TROUBLESHOOTING WAS PERFORMED. THE SHOCKING VECTOR WAS CHANGED TO RV COIL TO CAN AND THE IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE SYSTEM HAD OUT OF RANGE MEASUREMENTS IN THE TRIAD AND RV COIL TO RA COIL CONFIGURATIONS. THE PATIENT WILL CONTINUE TO BE MONITORED VIA THE REMOTE HOME MONITORING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620694 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 0185| F141