BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2920917 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01114
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    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 WAS EXHIBITING LOSS OF CAPTURE, SO A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION, IT WAS NOTED THAT THERE WAS A KINK IN THE LEAD LUMEN SO A STYLET COULD NOT BE PASSED THROUGH. THE KINK APPEARED TO BE CAUSED BY THE SUTURE WHEN THE LEAD WAS ORIGINALLY SECURED. AS A RESULT THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26641 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R K063| 4470| 4469