BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2170305 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10446
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 28, 2011
    Report Date
    May 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THIS RESULTED IN LOSS OF CAPTURE AND ASYSTOLE THAT WAS GREATER THAN 2 SECONDS LONG; IT WAS NOTED THAT THE PATIENT DID DEVELOP AN UNDERLYING RHYTHM OF 30BPM. A LEAD REVISION PROCEDURE WAS PERFORMED AND THIS RV LEAD WAS CAPPED, AND A NEW RV LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED RELATED TO THE ABOVE EVENTS.

    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 76 YR Hospitalization| L| R S603| 4456| 4469| 4470