BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2404044 · Received January 9, 2012

    Report

    Report Number
    2124215-2011-19302
    Event Type
    Injury
    Date Received
    January 9, 2012
    Date of Event
    October 24, 2011
    Report Date
    February 8, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED CIRCULAR FOOTPRINTS ON THE LEAD BODY INDICATING THAT THE SUTURE SLEEVE WAS TIED DOWN AT ABOUT 132-155 MILLIMETERS FROM THE TERMINA PIN. A FRACTURE IN BOTH THE ANODE AND CATHODE CONDUCTOR COILS WAS OBSERVED AT 155 MILLIMETERS FROM THE TERMINA PIN, WHICH IS AT THE DISTAL END OF THE SUTURE SLEEVE; HOWEVER, THERE WAS A SUTURE TIED DOWN DIRECTLY OVER THE FRACTURE. ANALYSIS INDICATED THE SUTURE WAS LIKELY USED AS PART OF THE EXTRACTION PROCESS DUE TO THE ADDITIONAL ANALYSIS RESULT REVEALED MECHANICAL FATIGUE DAMAGE AND ELECTROLYTIC PITTING ON THE SURFACE OF THE FRACTURE. THESE FAILURE CHARACTERISTICS REQUIRE TIME TO MATERIALIZE. THUS, THE SUTURE TIED DIRECTLY OVER THE FRACTURE WAS DEEMED COINCIDENTAL AND NOT AN ASSIGNABLE CAUSE. THE ASSIGNABLE CAUSE WAS LIKELY A FLEX FATIGUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE WHICH WAS OVERSENSED AND HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. A LEAD FRACTURE WAS SUSPECTED AND A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS EXPLANTED. IT WAS NOTED THAT THE PATIENT'S EJECTION FRACTION HAD INCREASED AND THE PHYSICIAN FELT A NEW SYSTEM WAS NOT NECESSARY AT THIS TIME DUE TO THE IMPROVEMENTS OF THE PATIENT'S CONDITION. 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 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 4469| 0185| E110