BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952288 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24153
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    August 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS WHICH TRENDED UP FROM 40 TO 104 OHMS. IN THE TRIAD CONFIGURATION, SHOCK IMPEDANCE MEASUREMENTS WERE 104 OHMS. IN THE RV COIL TO CAN CONFIGURATION, SHOCK IMPEDANCE MEASUREMENTS WERE 106 OHMS. IN THE RV TO RA COIL CONFIGURATION, SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 125 OHMS. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS NOT PERFORMED AT THE IMPLANT PROCEDURE. TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE CAUSES FOR THESE MEASUREMENTS AND SUGGESTED AN XRAY TO CONFIRM LEAD INTEGRITY AND REPROGRAMMING TO RV COIL TO CAN AND DOING A NIPS TO EVALUATE VF CONVERSION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THIS PATIENT CONTINUES TO HAVE HIGH SHOCK IMPEDANCE MEASUREMENTS. THE PATIENT WAS REFERRED TO THEIR ELECTROPHYSIOLOGIST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 0185| H179| 4513| N118| 4469