BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1953673 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23754
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED. IT WAS NOTED THAT THE PATIENT HAD BEEN RECENTLY IMPLANTED WITH AN EPICARDIAL LEAD, AFTER WHICH THE RIGHT ATRIAL LEAD WAS NOTED TO HAVE BEEN DISLODGED. IT WAS QUESTIONED IF ADDING THE EPICARDIAL LEAD CAUSED THE DISLODGEMENT. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention N119| 0185| 4542| 4470