BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3912211 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12143
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 12, 2014
    Report Date
    September 4, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE ALLEGATION AGAINST THE RIGHT VENTRICULAR (RV) LEAD COULD NOT BE CONFIRMED BY ANALYSIS. THE COMPLETE LEAD WAS RETURNED. TISSUE WAS NOTED AROUND THE TINES OF THE LEAD. THE LEAD THEN PASSED ALL OTHER ELECTRICAL TESTING.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS NOT SUCCESSFULLY IMPLANTED SINCE DURING THE IMPLANT PROCEDURE THIS LEAD PERFORATED THE HEART. ADDITIONAL INFORMATION INDICATES THAT DURING THE IMPLANT PROCEDURE THIS LEAD GOT CAUGHT ON THE TISSUE AND THE PHYSICIAN DECIDED TO REMOVE THIS LEAD. HOWEVER, THE PHYSICIAN HAD DIFFICULTY REMOVING THE LEAD. AFTER SEVERAL ATTEMPTS, THE LEAD WAS SUCCESSFULLY REMOVED. THIS LEAD WAS NEVER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390883 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R