BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173623 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11949
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    November 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR RESOURCES, THE LEAD REMAINS ACTIVELY IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS SUBSEQUENTLY PERFORMED AND A LEAD FRACTURE WAS REVEALED. THEREFORE, THE LEAD WAS WAS EXPLANTED AND REPLACED. THE PATIENT WAS UPGRADED TO A BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ----

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING NOISE, NO SENSING MEASUREMENTS AND WAS NOT CAPTURING IN BOTH BIPOLAR AND UNIPOLAR CONFIGURATIONS. ADDITIONALLY, IMPEDANCE MEASUREMENTS HAD INCREASED FROM 300 OHMS TO GREATER THAN 2500 OHMS IN ONE MONTH'S TIME. THE ASSOCIATED DEVICE WAS REPROGRAMMED TO VVI CONFIGURATION AND A LEAD REVISION WILL MOST LIKELY OCCUR IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention 1290| 4457| 4480