BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1771489 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13123
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 7, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS BEEN RETURNED FOR ANALYSIS. THIS EVENT WILL BE UPDATED AND RESUBMITTED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS ANALYZED. MICROSCOPIC ANALYSIS CONFIRMED THE LEAD WAS FRACTURED. BOTH CONDUCTOR COILS WERE FRACTURED APPROXIMATELY 195-200 MM FROM THE TERMINAL PIN. INSULATION DAMAGE AND A HOLE IN THE INSULATION WAS NOTED. VISUAL INSPECTION NOTED INDENDATIONS CONSISTENT WITH SUTURE SLEEVE TIE DOWN NEAR THE FRACTURE SITE. ANALYSIS OF THE FRACTURE SITE NOTED EVIDENCE OF FATIGUE. ANALYSIS CONCLUDED THE FRACTURE OCCURRED DUE TO CYCLIC STRESS OVER TIME.

    Description of Event or Problem · 1

    A LEAD FRACTURE WAS SUSPECTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ATRIAL LEAD HAD A PACING IMPEDANCE GREATER THAN 3000 OHMS. THE LEAD WAS NOT DELIVERING PACING PULSES, AND WAS NOT SENSING. THE LEAD WAS EXPLANTED AND REPLACED. 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 4470

    Patients

    Seq Age Sex Outcome Treatment
    1