BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1863658 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15869
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    June 28, 2010
    Report Date
    August 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LEAD WILL NOT BE RETURNED, CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A LEAD REVISION FOR ANOTHER LEAD, THIS CHRONIC RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH PACE IMPEDANCE GREATER THAN 2000 OHMS, THERE WAS INTERMITTENT LOSS OF CAPTURE AND SENSING ISSUES WERE OBSERVED WHEN THIS LEAD WAS CONNECTED TO THE EXISTING DEVICE. THESE OBSERVATIONS WERE NOT SEEN WHEN THE LEAD WAS TESTED WITH THE PACING SYSTEM ANALYZER. DESPITE FURTHER EVALUATION, THE PHYSICIAN WAS UNABLE TO DETERMINE WHETHER THERE WAS A CONNECTION/SETSCREW ISSUE OR A LEAD ISSUE. THE PHYSICIAN ELECTED TO REPLACE BOTH THE DEVICE AND THIS LEAD. THIS LEAD WAS SURGICALLY ABANDONED AND A NEW BOSTON SCIENTIFIC LEAD WAS SUCCESSFULLY IMPLANTED IN THE RA. 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 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR N118| H135| 0185| 4525| 4470