BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1951064 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23357
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RA LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED. THE INVESTIGATION IS CONSIDERED CLOSED. 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 THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD WAS DETERMINED TO BE FRACTURED DURING THE NORMAL DEVICE CHANGEOUT OF THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). LOSS OF CAPTURE AND NON-SENSING WERE ALSO EVIDENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS 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 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 4136| 4473| 1861| 0158| E110