BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 2061687 · Received April 18, 2011

    Report

    Report Number
    2124215-2011-06840
    Event Type
    Death
    Date Received
    April 18, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PREVIOUSLY ABANDONED LEAD PASSED AWAY DURING A SURGICAL PROCEDURE TO REMOVE THE COMPLETE SYSTEM DUE TO INFECTION AND DEVICE POCKET EROSION. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT DURING THE EXTRACTION OF ANOTHER MANUFACTURER'S ACTIVE LEAD A PORTION OF HEART TISSUE WAS REMOVED WITH THE LEAD. AN EMERGENCY THORACOTOMY WAS INITIATED IN AN ATTEMPT TO RESOLVE THE BLEEDING, BUT THE PROCEDURE WAS UNSUCCESSFUL AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death 1888TC| E110| 7002| 4480| 4457