BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2040735 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00845
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    March 4, 2011
    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

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED DRIED BODILY FLUID THROUGHOUT THE ENTIRE INSULATION. THE CONDUCTOR COIL WAS DEFORMED AT 213 MILLIMETERS (MM) FROM THE TERMINAL PIN DUE TO THE SUTURE SLEEVE TIE DOWN. THERE WAS A CUT NOTED IN THE INSULATION 88 TO 90 MM FROM THE TERMINAL PIN. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY OF THE LEAD. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO HAVE BLOOD IN THE INSULATION DURING A POCKET REVISION. IT WAS NOTED THAT THE POCKET REVISION WAS BEING DONE AFTER BLOOD WAS NOTED TO BE DRAINING FROM THE POCKET INCISION. THE PHYSICIAN ELECTED TO KEEP THE LEAD IMPLANTED AT THAT TIME AND TEST THE PATIENT FOR AN INFECTION. ALL LEAD MEASUREMENTS WERE NORMAL BY REPORT. THE PATIENT LATER TESTED POSITIVE FOR A POCKET INFECTION AND WILL BE SCHEDULED FOR A SYSTEM EXTRACTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE LEAD WAS LATER EXPLANTED AND WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 4136| 4459| S606