BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913294 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00230
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 2, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LEAD WAS CAPPED, IT WILL NOT BE RETURNED FOR LABORATORY ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. AN AMENDED REPORT WILL BE FILED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) PACING LEAD WAS SURGICALLY ABANDONED DUE TO HIGH CAPTURE THRESHOLDS AND HIGH PACING IMPEDANCE MEASUREMENTS. THE IMPEDANCES WERE 2,029 OHMS IN THE BIPOLAR CONFIGURATION AND 1,604 OHMS IN THE UNIPOLAR CONFIGURATION. AN X-RAY WAS PERFORMED, BUT NO FRACTURE WAS VISUALIZED. A NEW LEAD OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19878 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 5356| 4471| 4470