BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1862110 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15783
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT LV LEAD WAS NOT IMPLANTED AND NO ADVERSE EVENTS DURING THE PROCEDURE WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT HAD BEEN PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR AN ELECTIVE REPLACEMENT OF THE CHRONIC DEVICE DUE TO NORMAL BATTERY DEPLETION. THIS LEFT VENTRICULAR LEAD (LV) WAS SURGICALLY CAPPED DUE TO LOSS OF CAPTURE AND HIGH LV PACING IMPEDANCE MEASUREMENTS (GREATER THAN 2000 OHMS).

    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 57 YR Hospitalization| R 4470| 0185| H177| 4047| E110| 4549