BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1853524 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14764
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    April 19, 2010
    Report Date
    July 21, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IMPLANTED BUT OUT OF SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) PACE/SENSE LEAD WAS FOUND TO HAVE MIGRATED. IT WAS DISCOVERED WHEN THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SHORTNESS OF BREATH. THE PHYSICIAN OPTED TO CAP THIS CHRONIC RV LEAD AND REPLACE IT. NO OTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1