BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2171611 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11269
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 1, 2010
    Report Date
    June 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE ABANDONED LEAD HAS NOT BEEN RETURNED FOR ANALYSIS THEREFORE BOSTON SCIENTIFIC CANNOT CONFIRM THIS CLINICAL OBSERVATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS IN BIPOLAR CONFIGURATION AND WAS 400 OHMS IN UNIPOLAR CONFIGURATION. THE REPRESENTATIVE STATED THAT THE MEASUREMENTS MAY HAVE BEEN ELEVATED SINCE THE LAST ELECTIVE DEVICE REPLACEMENT PROCEDURE ONE YEAR PRIOR. DURING THE LEAD REVISION PROCEDURE, A LEAD FRACTURE WAS VISUALIZED. THE LEAD WAS ABANDONED SURGICALLY AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED OTHER THAN THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4473| 1280| 4459| S404