BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3040685 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00377
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    May 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN AND ANALYSIS, THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE COMPLETE LEAD WAS RETURNED. ANALYSIS REVEALED THAT THE COIL WIRES WERE FRACTURED NEAR THE TERMINAL PIN, AND THE ANODE WIRE WAS FRACTURED NEAR THE WELD. THERE WAS EVIDENCE THAT THE FRACTURE RESULTED IN TENSILE FORCE APPLIED ALONG WITH AN OVERLOAD OF FORCE, WHILE THE CATHODE WIRE SHOWED EVIDENCE OF A FAST FRACTURE AREA AND DIMPLES INDICATING THE WIRE FRACTURED AT A SHEAR BAND FROM AN OVERLOAD FORCE. LABORATORY ANALYSIS CONFIRMED THE CLINICAL ALLEGATION THROUGH ELECTRICAL TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR LEAD REVEALED OUT OF RANGE PACING IMPEDANCES. THE LEAD WAS REPLACED WITH A NEW LEAD. THE LEAD NOT IMPLANTED WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143872 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1