BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1952259 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23508
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 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

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC. THE INVESTIGATION IS CONSIDERED CLOSED. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD BECAME DISLODGED DURING THE PHYSICIAN'S REMOVAL OF THE RIGHT VENTRICULAR (RV) LEAD IN THE SYSTEM. THERE WAS NO ADVERSE PATIENT EFFECT 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 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR N119| 4470| 6949| 4136| 7299| 4194| 0185