BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2910830 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15924
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 PATIENT WAS OBSERVED TO HAVE AN UNUSUAL ELECTROGRAM (EGM) WHEN PACING IN THEIR RIGHT ATRIUM. THIS RIGHT ATRIAL (RA) LEAD WAS LATER FOUND TO HAVE DISLODGED ACCOUNTING FOR THE CHANGES OBSERVED ON THE PATIENT'S EGM. A REVISION PROCEDURE WAS PERFORMED IN WHICH THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18411 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R 4135| 4543| 0184| 4479| N119