BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2161298 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-08452
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD REVEALED THAT THE LEAD HAD BEEN SEVERED AT 299MM FROM THE TERMINAL PIN, 2 SEGMENTS WERE RETURNED, TOTAL LENGTH = 530 MM. DRIED BODY FLUID WAS NOTED THROUGH OUT THE ENTIRE LEAD LUMEN. ELECTRO-CAUTERY DAMAGE WITH MELTED INSULATION WAS NOTED 78, 85, 101 AND 185MM FROM THE TERMINAL PIN. THE CONDUCTOR COILS WERE CRUSHED AND SEPARATED AT 268 - 277MM FROM THE TERMINAL PIN. THIS TYPE OF DAMAGE IS CONSISTENT WITH CLAVICLE CRUSH. THE POLYURETHANE INSULATION WAS FLATTENED AT 268 - 277MM FROM THE TERMINAL PIN CONSISTENT WITH CLAVICLE CRUSH. THE CONDUCTOR COIL WAS CONFIRMED FRACTURED 275MM FROM THE TERMINAL PIN, ALSO CONSISTENT WITH CLAVICLE CRUSH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED PACING IMPEDANCES GREATER THAN 2,000 OHMS WITH NO THRESHOLD MEASUREMENTS. THE SAME ISSUE WAS NOTED ON THE COMPETITOR ATRIAL LEAD AS WELL. A CHEST X-RAY WAS PERFORMED AND REVEALED THAT THE TWO LEADS HAD BEEN FRACTURED AS THE CLAVICULAR LEVEL. IT WAS SUSPECTED THAT THE LEADS FRACTURED IN THIS AREA DUE TO THE PATIENT'S FREQUENT COUGHING AND MUSCLE CONSTRAINTS. A REVISION PROCEDURE WAS PERFORMED; BOTH THE ATRIAL AND VENTRICULAR LEADS WERE REMOVED AND REPLACED. THE RIGHT VENTRICULAR LEAD WAS RETURNED FOR ANALYSIS. NO ADDITIONAL 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 Other| R