BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1944967 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19547
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING ANALYSIS. THE EVENT WILL BE UPDATED ONCE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH A SET SCREW MARK ON BOTH OF THE TERMINALS AND TISSUE ENTWINED AT THE BASE OF THE HELIX. FURTHER VISUAL INSPECTION NOTED BLOOD AND BODY FLUID IN THE LEAD LUMEN DUE TO MULTIPLE CUTS IN THE INSULATION. DEFORMED CONDUCTOR COILS WERE ALSO OBSERVED AT 120 MM FROM THE TERMINAL PIN, AND ANALYSIS CONCLUDED IT WAS LIKELY DUE TO THE USE OF A GRABBING TOOL AT EXPLANT. ANALYSIS WAS NOT ABLE TO CONFIRM THE FIELD ALLEGATION OF DISLODGEMENT, HOWEVER THEY WERE ABLE TO CONFIRM THE LEAD BODY DAMAGE AND CONTAMINATION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THE TWO AND A HALF MONTHS POST IMPLANT THE RIGHT ATRIAL (RA) LEAD DISLODGED. WHEN THE LEAD WAS REMOVED FROM THE PATIENT DURING THE REVISION PROCEDURE, THERE APPEARED TO BE DAMAGE ON THE LEAD BODY NEAR THE SUTURE SLEEVE. FURTHER INSPECTION NOTED THAT THERE WAS ALSO INSULATION DAMAGE AND BLOOD IN THE LEAD LUMEN. A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE 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 69 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)