BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2060050 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05897
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    July 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD EXHIBITED LOSS OF CAPTURE AND PACING IMPEDANCES OF GREATER THAN 3000 OHMS. A LEAD REVISION PROCEDURE WAS PERFORMED WHERE THE LEAD WAS CUT AND CAPPED.

    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 72 YR Life Threatening| R 0185| E110| T165| 4471| 4470