BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951451 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22953
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    September 13, 2010
    Report Date
    November 24, 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

    THE LEAD WAS CAPPED AND SURGICALLY ABANDONED. 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 AN INCREASE IN PACING IMPEDANCE MEASUREMENTS, INCLUDING MEASUREMENTS GREATER THAN 2000 OHMS. INTERMITTENT CAPTURE WAS ALSO OBSERVED. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS CAPPED AND REPLACED. 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 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention T177| 0174