BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1853590 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14830
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PS DISCUSSED PROGRAMMING LEAD CONFIGURATIONS AND USE WITH RATE FEATURES. AT THIS TIME, THE LEAD REMAINS IN SERVICE. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT FIELD REPRESENTATIVE (FR) CALLED PATIENT SERVICES (PS) TO DISCUSS PROGRAMMING AROUND A QUESTIONABLE RIGHT VENTRICULAR (RV) LEAD FRACTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 4456| S603| 4135