BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2052819 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04396
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT CAUSED OVERSENSING AND PACING INHIBITION. PATIENT WAS IN COMPLETE HEART BLOCK. THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE PATIENT CONTACTED PATIENT SERVICES AND STATED THAT THE LEAD HAD DISLODGED. AN EMAIL WAS SENT TO THE BOSTON SCIENTIFIC SALES REPRESENTATIVE IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE THAT THERE WAS SOME PACING INHIBITION, BUT NOT LONG ENOUGH TO BE CLINICALLY RELEVANT. NO ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE LEAD REVISION PROCEDURE.

    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 81 YR Hospitalization| L| R 4456| S601| 4136| (B)(4)