BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1970217 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01050
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 27, 2010
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    UPON RECEIPT AT OUR (B)(4) LABORATORY, THE COMPLETE LEAD WAS RETURNED WITH ONE SET SCREW MARK NOTED ON EACH TERMINAL. TISSUE WAS OBSERVED ENTWINED IN THE HELIX AND BLOOD AND BODY FLUID WAS SEEN IN THE LEAD LUMEN. FURTHER VISUAL INSPECTION NOTED CUT AND PUNCTURE HOLES IN THE INSULATION ALONG WITH THE LEAD'S POLY INSULATION SLIGHTLY TWISTED IN A FEW LOCATIONS. THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. ANALYSIS CONFIRMED THE FIELD ALLEGATION OF DISLODGEMENT DUE TO TWIDDLER'S SYNDROME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT HAD DISLODGED THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS DUE TO TWIDDLER'S SYNDROME. THE LEADS WERE EXPLANTED AND NEW LEADS WERE SUCCESSFULLY IMPLANTED. THE PATIENT WAS NOTED TO BE IN COMPLETE HEART BLOCK. NO ADDITIONAL 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 81 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)