BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2780496 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12671
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 15, 2012
    Report Date
    September 15, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RA LEAD REMAINS IN SERVICE. 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, SHORTLY AFTER IMPLANT, HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED IN THE RIGHT ATRIUM (RA). THERE WAS ALSO NOTE OF LOSS OF CAPTURE (LOC) AND INCREASED THRESHOLD MEASUREMENTS. THIS PATIENT DID HAVE AN UNDERLYING RHYTHM, SO WAS NOT SYMPTOMATIC TO THE RA LOC. TESTING THE RA LEAD IN UNIPOLAR REVEALED A NORMAL IMPEDANCE OF 420 OHMS, P-WAVE OF 1.4MV AND A CAPTURE THRESHOLD OF 0.4V, THEREFORE UNDERINSERTION OF THE LEAD IN THE RA PORT WAS SUSPECTED. THE DECISION WAS MADE TO REPROGRAM THE DEVICE BY SPLITTING RA LEAD POLARITY (UNIPOLAR PACING/BIPOLAR SENSING). THERE WAS NO PLAN TO INTERVENE ANY FURTHER REGARDING THIS ISSUE. THIS PATIENT WILL RECEIVE NORMAL FOLLOW-UPS. THERE WERE NO ADVERSE PATIENT EFFECTS 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