BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1875058 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18211
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 6, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATIONS CONFIRMED THAT ONLY THE PROXIMAL SECTION OF THE LEAD WAS RETURNED MEASURING 33 CM IN LENGTH. THERE WERE SET SCREW MARKS NOTED ON TERMINAL PIN AND RING. THE COILS WERE COMPRESSED AT 12.3 CM FROM PIN LIKELY FROM USE OF A GRASPING TOOL. ANALYSIS FOUND THAT AT THE DISTAL END OF THE RETURNED LEAD PORTION, THE INSULATION APPEARED SLIGHTLY WORN, BOTH COILS WERE SLIGHTLY STRETCHED AND THE ENDS APPEARED FRACTURED. ANALYSIS REVEALS THE INSULATION WAS PARTIALLY ABRADED AND THE CONDUCTOR COILS WERE FOUND TO BE FRACTURED; THE TYPE OF DAMAGE AND LOCATION IS CONSISTENT WITH CLAVICLE FIRST/RIB ENTRAPMENT.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A CONDUCTOR FRACTURE WHICH WAS BELIEVED TO BE CAUSED BY CLAVICULAR CRUSH. IN A REVISION PROCEDURE, THE DISTAL PORTION OF THE LEAD WAS SURGICALLY ABANDONED AND THE PROXIMAL PORTION WAS EXPLANTED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A CONDUCTOR FRACTURE WHICH WAS BELIEVED TO BE CAUSED BY CLAVICULAR CRUSH. IN A REVISION PROCEDURE, THE DISTAL PORTION OF THE LEAD WAS SURGICALLY ABANDONED AND THE PROXIMAL PORTION WAS EXPLANTED. A NEW 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 4458

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R 4469| 4458| S603