BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1950487 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22770
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD HAS A SUSPECTED CONDUCTOR FRACTURE. SEVERAL MONTHS AGO, THE IMPEDANCE MEASUREMENTS JUMPED TO GREATER THAN 2000 OHMS. THE LEAD WILL BE SURGICALLY ABANDONED. TO DATE, THERE HAVE BEEN NO ADDITIONAL ADVERSE PATIENT EFFECTS 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 81 YR Required Intervention 1290| 4137| 4470| 4469