BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1871116 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17249
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED; THEREFORE THE COMPANY WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND WAS SUSPECTED OF HAVING MICRO-DISLODGED. IN A REVISION PROCEDURE THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED BY A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R 4470| S606| 5076| 4469