BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2162599 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07089
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT ATRIAL (RA) LEAD WERE EXHIBITING HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. PACING THRESHOLD MEASUREMENTS WERE UNABLE TO BE OBTAINED. A REVISION PROCEDURE TOOK PLACE AND THE RA LEAD WAS SURGICALLY ABANDONED. THE DEVICE WAS ALSO UPGRADED TO A BI-VENTRICULAR DEVICE. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE PROCEDURE.

    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 59 YR Life Threatening| R 4470| T167| 0185