BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2911955 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16529
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. VISUAL INSPECTION NOTED THE EXTRACTING STYLET WAS RETURNED IN THE LEAD LUMEN. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES WHICH WOULD HAVE CAUSED DISLODGEMENT. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE DUE TO LEAD DISLODGEMENT. AN INVASIVE PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED. THE FOLLOWING DAY, LOSS OF CAPTURE AT MAXIMUM OUTPUTS WAS OBSERVED. THE POCKET WAS REOPENED AND THIS LEAD WAS EXPLANTED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17127 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 4470| MISMATCH| K173| 1290| 1388TC| 4135