BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1951059 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23670
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE AND PACING IMPEDANCES GREATER THAN 3000 OHMS. A LEAD FRACTURE WAS SUSPECTED. A LEAD REVISION PROCEDURE WAS PERFORMED DURING WHICH THE LEAD WAS CUT AND CAPPED. THERE WERE 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 73 YR Life Threatening| R 4512| 0148| H135| H175| 4470