BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3040751 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01883
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 12, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION NOTED THAT THE LEAD WAS RETURNED SEVERED AT 48 5MM FROM THE TERMINAL PIN WITH THE CONDUCTOR COILS STRETCHED AND EXTENDING TO 52 4MM WHERE THEY HAD BEEN CUT. ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. A TEAR WAS NOTED IN THE TERMINAL SILICONE INSULATION SLEEVE AND THE INSULATION WAS MELTED NEAR THE DISTAL END, MOST LIKELY DUE TO EITHER LASER EXTRACTION OR ELECTRO-CAUTERY. BLOOD AND BODY FLUID WERE SEEN IN THE LUMEN. ANALYSIS WAS NOT ABLE TO CONFIRM THE ALLEGATION OF OFF LABEL USE, HOWEVER ANALYSIS DID SEE THE SEVERED PORTION OF THE LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE SYSTEM WAS TO ENDURE A MRI PROCEDURE. AS A RESULT, THIS DEVICE SYSTEM WAS EXPLANTED. DURING THE LEAD EXTRACTION PROCESS, THE LASER LEAD DISTAL TIP WAS SEVERED FROM THE REMAINING PORTION OF THE LEAD. THE DISTAL TIP REMAINS FIXED TO THE MYOCARDIUM. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144063 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening S606| 4471| 4470