BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3921717 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13638
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. AS THE LEAD WILL NOT BE RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. AN INVASIVE PROCEDURE WAS SUBSEQUENTLY PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. ADDITIONAL INFORMATION OBTAINED FROM A FIELD REPRESENTATIVE INDICATED THAT AN X-RAY SHOWED NO VISIBLE LEAD FRACTURE OR DISLODGEMENT. ADDITIONALLY, THE PACE IMPEDANCE MEASUREMENTS WERE OUT OF RANGE IN BOTH BIPOLAR AND UNIPOLAR CONFIGURATIONS AND THE PACING THRESHOLD MEASURED MORE THAN 6.5 VOLTS. FURTHERMORE, THE OUT OF RANGE MEASUREMENT WAS OBSERVED AS WELL THROUGH A PACING SYSTEM ANALYZER (PSA). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399976 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 4470| 4457| 4469| S602