BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2060099 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06070
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED. 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 PROCEDURE FOR DEVICE CHANGE OUT DUE TO UPGRADE, THIS LEAD WAS SCHEDULED FOR EXPLANT. THE LEAD WAS UNABLE TO BE REMOVED THROUGH THE SUPERIOR VENA CAVA (SVC), AND WAS SURGICALLY ABANDONED. THE LEAD REMAINS IN THE SVC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| S 0185| E110| 4470| 1290| 4471