BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2151589 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-05963
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. 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 A NEW DEVICE SYSTEM WAS SUCCESSFULLY IMPLANTED. UPON DEVICE CHECK LATER THAN DAY, WHAT APPEARED TO BE RIGHT VENTRICULAR (RV) NON-CAPTURE WAS OBSERVED. A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD APPEARED TO REMAIN IN THE APPROPRIATE POSITION, HOWEVER IT WAS OBSERVED THAT ALL OF THE SLACK WAS OUT OF THE RIGHT ATRIAL (RA) LEAD. THE LEADS WERE DISCONNECTED FROM THE DEVICE. ONCE THE IMPLANTING PHYSICIAN INSERTED THE STYLET INTO THE RV LEAD, IT DISLODGED FROM ITS ORIGINAL POSITION INTO THE APEX OF THE PATIENTS' HEART. THE RV LEAD WAS REVISED SUCCESSFULLY. THE IMPLANTING PHYSICIAN THEN PUT THE STYLET INTO THE RA LEAD AND ADDED SOME ADDITIONAL SLACK SUCCESSFULLY. NO FURTHER COMPLICATIONS WERE REPORTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED WITH 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 Required Intervention