BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2792710 · Received October 16, 2012

    Report

    Report Number
    2124215-2012-14035
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RA LEAD WAS SURGICALLY ABANDONED, SO THEREFORE WILL NOT BE RETURNED FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISPLAYED AN INCREASE IN PACING IMPEDANCE MEASUREMENTS, AND PACING THRESHOLD MEASUREMENTS. AN X-RAY WAS PERFORMED, WHICH REVEALED LEAD FRACTURE. THE DEVICE WAS REPROGRAMMED TO VVI MODE, AND THE PATIENT WILL UNDERGO A RA LEAD REVISION WITHIN THE NEAR FUTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT A SYSTEM REVISION WAS PERFORMED. THE ASSOCIATED DEVICE WAS EXPLANTED AND REPLACED, AND THIS RA LEAD WAS SURGICALLY ABANDONED.

    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 Hospitalization| L| R