BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1946210 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-21056
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 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 LOSS OF CAPTURE. ALL LEAD DIAGNOSTICS WERE ACCEPTABLE AND STABLE. DURING A NORMAL DEVICE CHANGE OUT PROCEDURE THIS 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 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 0158| 1861| 4244| T167