BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3913507 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12279
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 16, 2014
    Report Date
    September 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED SOON AFTER THIS LEAD WAS POSITIONED. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD; HOWEVER, THE LEAD BECAME STUCK AT THE TRICUSPID VALVE. PARTICULARLY, THE CHORDAE TENDINAE WAS CAUGHT UP BETWEEN THE HELIX AND THE DISTAL ELECTRODE OF THIS LEAD. THIS LEAD EVENTUALLY WAS LEFT IN PLACE AND ANOTHER RV LEAD WAS IMPLANTED SUCCESSFULLY. THIS LEAD WAS NEVER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391409 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 4471| J176| 4470