BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3211290 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08683
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION MADE AVAILABLE FROM A FIELD REPRESENTATIVE INDICATED THAT THEY DO NOT HAVE THE RIGHT VENTRICULAR (RV) LEAD AND THAT IF BOSTON SCIENTIFIC HAS NOT RECEIVED ANY PRODUCT, THAT THE HOSPITAL STILL HAS POSSESSION OF IT. THEREFORE, THE RV LEAD WILL NOT BE COMING BACK FOR ANALYSIS. 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

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS RIGHT VENTRICULAR (RV) LEAD SHOWED SIGNS OF GROSS DISLODGEMENT WITH POOR SENSING AND NO CAPTURE. THE LEAD WAS EXPLANTED AND A REPLACEMENT LEAD WAS SUCCESSFULLY IMPLANTED IN ITS PLACE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309033 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4136| S606| 4135| 4456| 4469