BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3040702 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00656
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    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

    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 DURING A SYSTEM EXTRACTION DUE TO INFECTION, THIS RIGHT ATRIAL (RA) LEAD WAS UNABLE TO BE FULLY EXTRACTED. THE LEAD DID NOT BREAK APART, HOWEVER, THE TIP WAS UNABLE TO BE REMOVED. THE PROCEDURE WAS ABANDONED AND THE LEAD WAS COILED IN THE POCKET. A SECOND PROCEDURE WAS PERFORMED THE FOLLOWING DAY. THE RA LEAD WAS SUCCESSFULLY LASER EXTRACTED WITH NO ILL EFFECTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142813 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 4469| 4135| 4136| S606