BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2052849 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03804
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS ATTEMPTED RA LEAD WAS TO BE RETURNED TO BOSTON SCIENTIFIC, THE RV LEAD REMAINS IN SERVICE. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHILE ATTEMPTING TO IMPLANT THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD, FRICTION RESULTED WITH THE RIGHT VENTRICULAR (RV) LEAD, THAT THEN CAUSED THE RV LEAD TO BECOME DISLODGED. IT BECAME DIFFICULT FOR THE PHYSICIAN TO POSITION ONE LEAD WITHOUT THE OTHER MOVING/DISLODGING. A NON-BSC RA LEAD WAS USED IN LIEU. THERE WERE NO ADVERSE PATIENT SYMPTOMS REPORTED ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR S606| 4469| 4136| (B)(4)