BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2061020 · Received April 18, 2011

    Report

    Report Number
    2124215-2011-06750
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    September 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUBSEQUENTLY RETURNED FOR TESTING. RESISTANCE TESTING CONFIRMED ALL CONDUCTIVE PATHWAYS OF THE RETURNED SEGMENTS ARE CONTINUOUS. ADDITIONALLY, AN X-RAY SHOWED NO FRACTURE WAS OBSERVED WHERE THE EXTRACTING STYLET RESIDED. THEREFORE, FINAL TESTING WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    -----

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS EXHIBITING ELEVATED THRESHOLD AND IMPEDANCE MEASUREMENTS. A REVISION PROCEDURE WAS PERFORMED AND A LEAD FRACTURE WAS REVEALED. THE LEAD WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R (B)(4)| 5826| 4469| 1280| 4456| S606| MISMATCH