BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3210069 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06644
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    September 6, 2011
    Report Date
    April 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACING IMPEDANCES OF THIS RIGHT ATRIAL LEAD HAD BEEN RISING GRADUALLY, BUT MOST RECENTLY WERE REPORTED TO BE OUT OF RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309239 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1