BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2060123 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06024
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS BEEN PARTIALLY EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE OUT PROCEDURE DUE TO ELECTIVE REPLACEMENT, THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO CHRONICALLY HIGH PACING THRESHOLDS. DURING THE EXPLANT, THE TIP OF THE RA LEAD WAS BROKEN OFF AT THE SUPERIOR VENA CAVA/SUBCLAVIAN JUNCTION. THE REST OF THE LEAD WAS SUCCESSFULLY EXPLANTED. NO ADDITIONAL ADVERSE EFFECTS DUE TO THE REMOVAL DIFFICULTY WERE NOTED.

    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 64 YR Life Threatening| S 0185| N119| 4470| H175| 4542| 4518