BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1945885 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20937
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    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

    TECHNICAL SERVICES DISCUSSED OTHER LEAD DIAGNOSTICS AND RECOMMENDED MONITORING THE LEAD. THE AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. THE PATIENT HAD UNDERGONE A SURGICAL PROCEDURE ONE DAY PRIOR. SENSING MEASUREMENTS HAD DECREASED FROM 10 MV TO 5 MV. THE PATIENT WAS BROUGHT IN ORDER TO PERFORM DEFIBRILLATION THRESHOLD (DFT) TESTING. TESTING YIELDED A 29 OHMS SHOCK IMPEDANCE MEASUREMENT WITH SHOCK DELIVERY. 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 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 4543| N119| 4136| 0185