BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1962305 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00947
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 FROM AN IMPLANT FORM THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY LABORATORY FOR A DEVICE REPLACEMENT AND ILEAD REVISION PROCEDURE. THE RIGHT VENTRICULAR (RV) PACE/SENSE LEAD WAS SURGICALLY CAPPED AND REPLACED DUE TO INTERMITTENT CAPTURE AT MAXIMUM OUPUT. THERE WERE NO ADVERSE EVENTS REPORTED.

    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 58 YR Hospitalization| L| R 1290| 4456| S603| 4136| 4086