BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173195 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10695
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    January 4, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD IS NOT EXPECTED FOR RETURN AS IT WAS SURGICALLY ABANDONED. 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 AVAILABLE INFORMATION SUGGESTS THIS LEAD AND DEVICE 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. ALL OTHER DIAGNOSTICS WERE GOOD AND STABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS EXPLANTED DUE TO DECLARING ELECTIVE REPLACEMENT INDICATOR (ERI). DURING THE DEVICE REPLACEMENT PROCEDURE, THIS LEAD WAS CAPPED AND SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR H219| 4518| 4480| H179| 0148