BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3050057 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05524
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 LOSS OF CAPTURE WAS NOTED AT HIGHER OUTPUTS, AND A FOLLOW-UP X-RAY CONFIRMED THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED. IT WAS THOUGHT THAT DEVICE MIGRATION PULLED THE SLACK OUT OF THE ATRIAL LEAD AND EVENTUALLY BECAME TOO TIGHT, THEREBY LEADING TO LEAD DISLODGEMENT. MULTIPLE ATTEMPTS WERE MADE TO ACTIVELY RE-FIXATE THE LEAD. HOWEVER, IT KEPT DISLODGING. THEREFORE, THE LEAD WAS EXPLANTED AS THE PHYSICIAN WAS AFRAID THERE MAY BE TISSUE IN THE HELIX. THIS WAS, INDEED THE CASE; GROSS TISSUE WAS NOTED IN THE HELIX UPON EXPLANT. A NEW RA LEAD WAS IMPLANTED, INSTEAD. NO ADVERSE PATIENT EFFECTS. THE LEAD WILL NOT BE RETURNED TO BSC. ALTHOUGH THIS LEAD WAS REQUESTED FOR RETURN, THE LEAD WAS DISCARDED BY THE CATH LAB STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149555 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4470| K173| 4471