BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2060983 · Received April 18, 2011

    Report

    Report Number
    2124215-2011-06743
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVASIVE PROCEDURE WAS PERFORMED TO ASSESS THE LEAD. THE LEAD WAS DISCONNECTED FROM THE DEVICE AND TESTED. MEASUREMENTS WERE ACCEPTABLE, THEREFORE THE LEAD WAS NOT REPOSITIONED. THE LEAD WAS THEN RE-INSERTED INTO THE HEADER AND THE SETSCREWS WERE TIGHTENED. MEASUREMENTS WERE ACCEPTABLE WHEN THE LEAD WAS RECONNECTED WITH THE DEVICE. IT WAS SUSPECTED THE CONNECTION BETWEEN THE LEAD AND DEVICE WAS NOT COMPLETE, RESULTING IN THE CLINICAL OBSERVATIONS. THIS LEAD AND DEVICE REMAIN IN SERVICE. 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 FOLLOWING A NORMAL DEVICE REPLACEMENT PROCEDURE, THIS CHRONIC IMPLANTABLE DEFIBRILLATION LEAD AND THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE ON THE RATE/SENSE CHANNEL. PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS WERE ALSO OBSERVED. IT WAS REPORTED THE PATIENT IS PACER DEPENDENT AND THE NOISE RESULTED IN APPROXIMATELY FOUR SECONDS OF PACING INHIBITION. ANTITACHYCARDIA PACING (ATP) WAS INAPPROPRIATELY DELIVERED DUE TO THE NOISE. AN INCREASE IN RIGHT VENTRICULAR PACING THRESHOLD MEASUREMENTS WERE ALSO REPORTED. THE RIGHT VENTRICULAR OUTPUT WAS THEN INCREASED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 0158| T125| H175| 4518| N118| 4244