BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2780045 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12122
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD IS NOT EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC. WITHOUT A RETURNED LEAD, IT IS NOT POSSIBLE TO CONDUCT TECHNICAL ANALYSIS AND DETERMINE HOW THE LEAD MAY HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT INCIDENT. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE. THOUGH THE LEAD WAS REPOSITIONED, IT STILL SHOWED HIGH OUT OF RANGE PACING IMPEDANCE EACH TIME. THIS LEAD WAS REMOVED AND A NEW RV LEAD WAS IMPLANTED WITH NO PROBLEMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1