BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 1981349 · Received February 8, 2011

    Report

    Report Number
    2124215-2011-02299
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 4479 LEAD REMAINED IMPLANTED IN THE PATIENT. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPIRED DURING THE IMPLANT PROCEDURE. DURING RIGHT ATRIAL (RA) LEAD PLACEMENT A 4135 LEAD WAS ATTEMPTED AND REMOVED DUE TO DISLODGEMENT. A NEW 4479 LEAD WAS IMPLANTED AND DURING THE IMPLANT OF THIS RA LEAD THERE WAS A SUDDEN DECREASE IN BLOOD PRESSURE, THE PATIENT CODED AND EXPIRED. THE CARDIOLOGIST STATED THAT DURING THE LEAD PLACEMENT, CLOTS IN THE RA WERE SENT THROUGH THE BLOOD SYSTEM AND CAUSED THE PATIENT DEATH. NO OBVIOUS LEAD PERFORATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death 4479| 0185| 4135